Technical Monograph A SANOFI COMPANY

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1 Technical Monograph A SANOFI COMPANY

2 NexGard TM Fleas can cause considerable discomfort and health problems for pets, and infestations can be difficult to eliminate and frustrating for owners. At the same time, ticks are expanding in number and geographic range, putting dogs at greater risk for vector-borne diseases. Now, with NexGard, dog owners can effectively kill adult fleas, treat and prevent flea infestations, and treat and control ticks with the convenience of a palatable, soft, beef-flavored chew. This monthly flea and tick treatment contains afoxolaner, a molecule developed for veterinary medicine. For the entire month, NexGard kills Ctenocephalides felis fleas before they can lay eggs, preventing subsequent flea infestations. This oral medication also provides sustained, month-long killing of black-legged ticks (Ixodes scapularis), American dog ticks (Dermacentor variabilis), and Lone star ticks (Amblyomma americanum). 1 NexGard is an FDA-approved product that has demonstrated safety and excellent efficacy in pivotal laboratory studies and in client-owned dogs. (afoxolaner) Chewables: The First Oral Flea and Tick Treatment for Dogs Table of Contents page 4 NexGard Highlights 6 Afoxolaner: An Isoxazoline Molecule for the Treatment of Fleas and Ticks 8 Pharmacokinetics 12 Pharmacodynamics 14 Treatment and Prevention of Flea Infestations 16 Efficacy Against Pre-existing Flea Infestations 17 Kills Fleas Fast, Before They Can Lay Eggs 18 Efficacy Against New Flea Infestations Prevention of Egg Production 22 Field Efficacy Data 24 Canine Tick-borne Diseases 26 Efficacy Against Ticks 3 Safety Studies 34 Product Composition and Packaging 35 Administration 37 Package Insert 38 References 2 skin, diarrhea, lethargy, and lack of appetite. Use with caution in dogs with a history of seizures. 3

3 NexGard Highlights NexGard is indicated for the treatment and prevention of flea (Ctenocephalides felis) infestations and the treatment and control of black-legged tick (Ixodes scapularis), American dog tick (Dermacentor variabilis), and Lone star tick (Amblyomma americanum) infestations in dogs and puppies 8 weeks of age and older, weighing 4 lbs of body weight or greater, for 1 month. 1 Afoxolaner: A Molecule Developed for Veterinary Medicine NexGard contains afoxolaner, a novel member of the isoxazoline chemical class. Afoxolaner kills fleas and ticks by targeting a distinct binding site within nerve cell membrane GABA (gamma aminobutyric acid) modulated chloride channels, resulting in uncontrolled hyperexcitation and death. 1 Flea and Tick Control in a Palatable, Soft, Beef-Flavored Chew With braised-beef flavoring, each NexGard chew features a meaty appearance, chewy texture, and beefy aroma. The soft chew provides clients with ease of administration. Works Fast Against Flea Infestations 1 Starts killing fleas within 4 hours after treatment. Kills adult fleas before they can lay eggs, reducing environmental flea biomass (eggs, larvae, and pupae). Prevents reinfestation with new fleas. Keeps Killing Adult Fleas All Month Long 1 With new infestations, the majority of adult fleas are killed within 12 hours. In a well-controlled study, of fleas were killed within 24 hours throughout the monthly treatment period. In a field study, NexGard reduced fleas by 98.% to 99.9% over the course of 3 monthly treatments. Kills Ticks for 1 Month 1 In studies, NexGard provided month-long killing power against I. scapularis, D. variabilis, and A. americanum ticks. No Need to Administer With Food Most dogs readily take the palatable chew, so there is no need to hide it in food. 2 Afoxolaner plasma levels are the same regardless of whether NexGard is given with or without food. 3 4 skin, diarrhea, lethargy, and lack of appetite. Use with caution in dogs with a history of seizures. 5

4 Afoxolaner: Developed for the treatment of fleas and ticks in veterinary medicine Afoxolaner is a novel member of the isoxazoline class of compounds. 4 This class of parasiticides was developed to deliver exceptional activity against a broad range of pests via potent blocking of nerve cell membrane GABA (gamma aminobutyric acid) modulated chloride channels in fleas and ticks. Isoxazolines comprise a wide array of naturally occurring and synthetic compounds. Some of these confer adaptive and protective capabilities, such as in certain sea sponges, in which isoxazoline alkaloids help protect them from a species of sea snails that feed on the sponges. 5 Additionally, isoxazoline derivatives display significant therapeutic potential because of their antiparasitic, anti-inflammatory, antimicrobial, anticancer, anti-hiv, fibrinogen receptor antagonistic, caspase inhibitory, and antidepressant properties. 6 9 Certain synthetically derived isoxazoline compounds also show activity against insects and acarines, including fleas and ticks. Afoxolaner: The Molecule Chemical name: 1-Naphthalenecarboxamide, 4-[5-[3-chloro-5-(trifluoromethyl)phenyl]- 4,5-dihydro-5-(trifluoromethyl)-3-isoxazolyl]-N-[2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl]- Molecular formula: C 26 H 17 ClF 9 N 3 O 3 Structural formula: F 3 C CI F 3 C Molecular weight: O N Unique characteristics: Afoxolaner has a low molecular weight and is highly bound (99%) to plasma proteins. The compound has low aqueous solubility because it is lipophilic, hydrophobic, and non-ionizable. Afoxolaner crosses cell membranes freely via passive diffusion driven by concentration gradients. O H N O N H CF 3 Development of Afoxolaner: A Veterinary Prescription Drug for Treating Fleas and Ticks A group of trisubstituted isoxazoline compounds that displayed excellent activity against the cat flea (Ctenocephalides felis) were identified. From these compounds, afoxolaner was selected for further evaluation. Afoxolaner Safety Safety evaluations of afoxolaner across multiple species demonstrated a general lack of systemic, dermal, ocular, neurologic, reproductive, or genetic toxicity. Laboratory animal studies in rodents evaluated oral doses up to 1, mg/kg in rats and 2, mg/kg in mice. 11 No mortality was observed; the only effects reported in rats were reductions in food consumption and body weight. Afoxolaner is nonirritating to skin and only slightly irritating to the eyes. In specialized studies in rats and rabbits, afoxolaner was not found to be a reproductive toxicant. 12 Promising Proof-of-Concept Studies Discovery studies in dogs demonstrated that afoxolaner was effective at controlling fleas and ticks on dogs for at least 1 month when administered orally at a dose of 2.5 mg/kg. A series of in vitro and in vivo proof-of-concept studies were performed using an experimental oral solution of afoxolaner. Results of these studies provided an indication for: The blood concentration of afoxolaner necessary to kill fleas In vivo safety and efficacy of afoxolaner against multiple flea and tick challenges The pharmacokinetic characteristics of afoxolaner The molecule s unique insecticidal/acaricidal mode of action Unlikely potential for cross-resistance to commonly used insecticides Strong support for afoxolaner as an excellent choice for further development Mode of Action: The GABA-Gated Chloride Channel Afoxolaner kills fleas and ticks by binding to insect and acarine nerve cell membrane chloride channels, gated by the neurotransmitter GABA, thereby blocking the flow of chloride ions across cell membranes and inhibiting the firing of new action potentials. 4 Binding to glutamategated chloride channels has also been noted. 13 Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. Safety evaluations of afoxolaner across multiple species demonstrated a general lack of systemic, dermal, ocular, neurologic, reproductive, or genetic toxicity. Although GABA-gated chloride channels are also target receptors of fipronil and cyclodienes (dieldrin), afoxolaner is unique because it targets a distinct site within the pentameric protein complex in which the chloride channel is situated. 4,14 Cross-resistance studies using insects carrying the point mutation at the Rdl gene locus in GABA-gated chloride channels 4 found no cross-resistance of afoxolaner with dieldrin, demonstrating that afoxolaner acts on a unique receptor site. 6 skin, diarrhea, lethargy, and lack of appetite. Use with caution in dogs with a history of seizures. 7

5 Afoxolaner Pharmacokinetics Afoxolaner s slow clearance gives it a long half-life in dogs and sustained ectoparasitic activity. After oral administration to dogs, afoxolaner is rapidly absorbed into the systemic circulation, where the drug becomes active against fleas and ticks upon a blood meal. Afoxolaner is highly protein bound (>99%), while unbound afoxolaner distributes moderately into tissues. 3 The single exponential decay of afoxolaner in plasma during the terminal phase from Day 2 to 3 months suggests that no special tissue depots are present in the dog. This is consistent with the physical chemical properties of afoxolaner, which favor passive diffusion into and out of tissues. Afoxolaner is slowly eliminated from the body via biliary excretion of free afoxolaner and via hepatic metabolism and subsequent biliary and renal clearance of afoxolaner metabolites. This slow clearance gives afoxolaner a long half-life in dogs and sustained ectoparasitic activity. Pharmacokinetic Studies Demonstrated Rapid Absorption and Long Half-Life of Afoxolaner In vivo studies 3 were performed to evaluate the pharmacokinetics and oral bioavailability of afoxolaner in dogs. In another study, 32 mongrel dogs were randomly assigned to four groups of eight dogs. Dogs in three of the groups were administered an oral chew with increasing doses of afoxolaner for each group (1., 2.5, and 4. mg/kg). The control group received an oral chew without afoxolaner. Pharmacokinetic Parameters for Afoxolaner Following Oral Administration of Afoxolaner in a Soft, Beef-Flavored Chew Mongrel Dogs, n=8/group Parameter Group 2 Group 3 Group 4 Route of administration Oral chew Oral chew Oral chew Dose (mg/kg) 1.1 ± ± ±.3 T max (hr) 2 to 6 2 to 4 2 to 6 C max (ng/ml) 538 ± 85 1,384 ± 33 2,147 ± 575 T 1/2 (day) 14.4 ± ± ± 9. In an oral bioavailability study, 12 fasted beagles were assigned to two groups of six dogs. One group was administered 1 mg/kg of afoxolaner intravenously delivered in 1 ml of a polyethylene glycol (PEG) 4:ethanol (8:2 v/v) solution, and another group was administered an oral chew with an afoxolaner dose of 2.83 mg/kg. Following oral administration, afoxolaner: Was rapidly absorbed (T max = 2 to 4 hours) Achieved a maximum plasma concentration (C max ) of 1,655 ± 332 ng/ml Demonstrated a bioavailability of 73.9% Exhibited a terminal plasma half-life (T 1/2 ) of 15 days Concentration (ng/ml), 1, Time (days) 1. mg/kg 2.5 mg/kg 4. mg/kg At all dose levels, afoxolaner plasma concentrations maintained dose proportionality throughout the measurement intervals. Mean Afoxolaner Plasma Concentration Over Time The maximum afoxolaner plasma concentration after dosing (C max ) was proportional to the dose administered. Time to maximum concentration (T max ) and terminal plasma halflives (T 1/2 ) were similar over the dose range evaluated. 8 skin, diarrhea, lethargy, and lack of appetite. Use with caution in dogs with a history of seizures. 9

6 Feeding Has No Impact on the Pharmacokinetic Profile of Afoxolaner Because the pharmacokinetic characteristics of afoxolaner in fed and fasted dogs are essentially the same, there is no need to administer afoxolaner with food. Concentration (ng/ml), 1, The chewable formulation of afoxolaner was administered to five fed and five fasted dogs to determine whether food affects the pharmacokinetic characteristics of afoxolaner. 3 Dogs in the first treatment group were fed before treatment, and dogs in the second treatment group were fasted overnight, before treatment, and for 4 hours after treatment. Blood samples were collected until Study Day There was no difference in maximum plasma afoxolaner concentrations (C max ) between fed (1,366 ± 276 ng/ml) and fasted (1,453 ± 374 ng/ml) dogs, and the dogs overall afoxolaner exposure (AUC inf ) was not affected by their preprandial state. Plasma Concentration of Afoxolaner Over Time in Fed and Fasted Dogs 15 Fasted Fed A Pivotal Study Demonstrated Low Accumulation of Afoxolaner After Multiple Doses The multiple-dose kinetics of afoxolaner were investigated in this study. 3 Three male and three female beagle dogs were administered afoxolaner orally in a PEG 4:ethanol (8:2 v/v) solution via gavage once a month for 3 months (Days, 28, and 56). Blood was collected at regular intervals and through 28 days after the last dose. Steady state was reached by the third monthly dose. There was low accumulation of afoxolaner, and the ratio for C max was 1.3 (a 3% increase from Dose 1 to Dose 3). The half-life was comparable after each of the three monthly doses. These parameters indicate that the clearance, distribution, and absorption processes are neither saturated nor induced after monthly dosing and the kinetics are linear. Concentration (ng/ml) 2, 1,6 1, 8 4 Experimental multiple-dose data Simulation based on 2-compartmental analysis of single-dose data The pharmacokinetic properties of afoxolaner are ideal for a monthly administered parasiticide because the fast absorption and long terminal half-life support month-long efficacy. Experimental and Simulated Afoxolaner Plasma Concentration Over Time Time (days) Time (days) skin, diarrhea, lethargy, and lack of appetite. Use with caution in dogs with a history of seizures. 11

7 Afoxolaner Pharmacodynamics Afoxolaner acts systemically, and a strong correlation was found between plasma concentration and efficacy. A pharmacokinetic/pharmacodynamic model was used to describe the relationship between afoxolaner plasma concentration and percent efficacy. 3 Data for flea efficacy at 24 hours and tick efficacy at 48 hours were compared with concurrent plasma afoxolaner levels using a sigmoidal E max model. The EC 9, or the afoxolaner plasma concentration estimated to provide 9% efficacy, was calculated using this model. Pharmacokinetic/ pharmacodynamic modeling demonstrates that a single 2.5 mg/kg dose of afoxolaner maintains blood levels well above the minimum active dose needed to kill fleas and ticks for the monthly treatment period. Mean Percent 24-Hour Efficacy Against Ctenocephalides felis as a Function of Afoxolaner Plasma Concentration Mean Percent 48-Hour Efficacy Against Dermacentor variabilis as a Function of Afoxolaner Plasma Concentration Flea Efficacy (%) Observed Predicted Tick Efficacy (%) Observed Predicted Afoxolaner Plasma Concentration (ng/ml) Afoxolaner Plasma Concentration (ng/ml) The EC 9 value* for C. felis was determined to be 23 ng/ml. The EC 9 value* for D. variabilis was determined to be 1 ng/ml. *EC 9 = plasma afoxolaner concentration at which 9% of fleas were killed within 24 hours after infestation on dogs. *EC 9 = plasma afoxolaner concentration at which 9% of ticks were killed within 48 hours after infestation on dogs. 12 skin, diarrhea, lethargy, and lack of appetite. Use with caution in dogs with a history of seizures. 13

8 Flea Infestation: Providing Relief and Breaking the Cycle The Goals of Flea Control Effective flea control should provide relief to the pet and eliminate premise infestation. 16 Control of flea infestations is mainly based on the regular administration of flea adulticide products that accomplish these objectives through rapid speed of kill and killing fleas before they can lay eggs. Insect growth regulators and juvenile hormone analogues prevent development of flea eggs that are produced, but they do not provide relief to the pet or address other flea-related health issues. Dogs are primarily infested by two flea species: the cat flea, Ctenocephalides felis felis, and the dog flea, Ctenocephalides canis. C. felis is the predominant flea species found on dogs and cats in the United States and worldwide. 17 Fleas are responsible for several clinical signs, including pruritus, alopecia, pale mucous membranes associated with anemia, and seborrhea. Flea saliva can also lead to the development of flea allergy dermatitis (FAD). Characteristics of a Flea Infestation By the time a pet owner notices fleas on her pet, the home environment may already be teeming with a large biomass of flea eggs, larvae, and pupae. Fleas are the carrier of pathogens, including Rickettsia felis, Bartonella henselae, and Mycoplasma (hemoplasma), and the tapeworm Dipylidium caninum. In addition to infesting dogs and cats, C. felis readily infest numerous species of wild animals (canids, opossums, raccoons), domestic rabbits, and hedgehogs. C. felis will bite humans but Untreated pets will not establish a permanent infestation on people. become the center of a cycle of infestation, harboring reproducing fleas and seeding the environment with flea eggs. Sources of Flea Infestation All of the animal species that are suitable hosts for the cat flea share habitats with people and their pets, and as a result, sites of flea development are ubiquitous. Part of what makes fleas so insidious is that they can infiltrate a pet owner s home so easily: Once on a preferred host, cat fleas start feeding within minutes and begin breeding. A female flea can start laying eggs within 24 hours and can produce 4 to 5 eggs per day. 18 Feral cats and wildlife such as raccoons, opossums, and foxes can be heavily infested with cat fleas and are an important source of flea eggs. Newly emerged fleas from these eggs can jump on a pet when it explores areas where these animals have taken shelter. Fleas can hitch a ride inside on people s clothing. Untreated, infested pets that are visiting a home can leave fleas and flea eggs behind. Dog parks, campsites, doggy daycare, and kennels can be hot spots for flea development. An untreated dog can become infested and seed its home with flea eggs. Development from eggs to larvae, pupae, and emerged fleas only takes about 3 weeks at 75 F. 17 By the time pet owners notice fleas on a pet and start treatment, they most likely have a flea infestation that has been developing under their feet for several weeks. Key Factors in Successfully Treating and Preventing Flea Infestations An effective parasiticide must: Start killing adult fleas quickly to minimize their feeding and reproductive abilities Disrupt the flea life cycle by killing fleas before they can lay eggs Continue providing flea-killing power for the entire treatment period to prevent new infestations After a dog is treated with a flea adulticide, flea egg production is disrupted. An existing biomass of flea eggs, larvae, and pupae can still run its course, resulting in more fleas emerging into the environment until the biomass is exhausted. With monthly treatment with a long-lasting flea adulticide, new flea infestations will be prevented

9 Studies Demonstrating NexGard Efficacy Against Fleas (Ctenocephalides felis) Study Group In a Well-Controlled Laboratory Study, NexGard Began to Kill Fleas 4 Hours After Initial Administration and Demonstrated >99% Effectiveness at 8 Hours 1 An in vivo study was conducted to demonstrate the curative efficacy of NexGard against a pre-existing infestation of cat fleas (C. felis). Study Design 19 Healthy beagles of either sex, 13.8 to 37.5 months of age and weighing 7.5 to kg, were randomly assigned to the groups shown in the table at left. Number of Dogs 1 (Control) None Treatment 2 NexGard chew All dogs were infested with unfed C. felis fleas on Day 1. Treated dogs were administered a NexGard chew on Day to achieve a minimum afoxolaner dose of 2.5 mg/kg of body weight. Live fleas were counted upon removal at 4, 8, 12, and 24 hours after treatment. For each time point, flea counts were performed on 4 dogs from each of the control and treatment groups. After Treatment, NexGard Kills Fleas Fast, Before They Can Lay Eggs Flea egg counts were performed to assess the effectiveness of NexGard to reduce flea egg production on dogs that were pre-infested with C. felis the day before treatment. Flea egg counts were significantly reduced (P.28) in comparison with the control group at 12 and 24 hours post-treatment, demonstrating that NexGard kills fleas fast, significantly reducing egg production from a flea infestation already established on the dog. Counts of Flea Eggs Collected From Dogs 12 and 24 Hours After Treatment of a Pre-existing Flea Infestation Hours After Treatment Control Group Geometric Mean (Range) NexGard Group Geometric Mean (Range) (4 9) 1.7 ( 11) ( 118) 3.9 (1 17) These results demonstrate that NexGard kills fleas fast after treatment. Because fleas can start laying eggs as soon as 24 hours after infestation, 18 the fleas on these pre-infested dogs were competent to lay eggs at the time of treatment. Percent Curative Efficacy of NexGard Against an Existing Cat Flea Infestation % 99.5% P=.64 P<.1 P<.1 P<.1 4 hours 8 hours 12 hours 24 hours Time After Treatment % 12 hours after treatment Ctenocephalides felis Egg Count Reduction Efficacy 12 Hours After Treatment With NexGard in Dogs Pre-infested With Fleas the Day Before Treatment 16 Four hours after treatment, flea counts were reduced 87.8% compared to flea counts on untreated dogs. NexGard demonstrated 99.5% efficacy against an existing flea infestation 8, 12, and 24 hours after treatment.. skin, diarrhea, lethargy, and lack of appetite. Use with caution in dogs with a history of seizures. 17

10 In New Flea Infestations, NexGard Kills Adult Fleas Within 12 Hours for a Full Month Even after existing flea infestations are eliminated, a dog can be exposed to several sources of continual reinfestation. Effective flea control requires treatments that continue to provide flea-killing power throughout the entire month. Two in vivo studies 21 were conducted to determine the efficacy of orally administered NexGard against repeated infestations with adult C. felis on dogs. Study Design The two studies used a total of 64 healthy beagles (34 males, 3 females) that were >6 months of age and weighed 8.2 to 19.6 kg. Within each study, the dogs were randomly assigned to the following groups: Treatment Group Number of Dogs Assessment None 8 12-hour efficacy For flea counts at 12 hours after infestation, NexGard efficacy was 95.2% through Day 21 in both studies. Efficacy continued at high levels and was 93.% on Day 35 in Study 1 and 89.7% on Day 35 in Study % 99.1% 97.5% *Percent efficacy = [(C T)/C], where T and C are the geometric mean flea counts of treated and control groups, respectively. 99.5% 97.7% Day 7 Day 14 Day 21 Day 28 Day % Flea Infestation Day 81.1% 98.5% 93.% 89.7% Study 1 Study 2 Percent Efficacy* of NexGard 12 Hours After Flea Infestation On Day, treated dogs were administered NexGard orally to achieve a minimum afoxolaner dose of 2.5 mg/kg of body weight. All dogs were experimentally infested with ± 5 unfed C. felis fleas on Days 7, 14, 21, 28, and 35. Live fleas were counted at 12 and 24 hours after infestations on Days 7, 14, 21, 28, and 35, according to count-by-time block assignments in each group. Results NexGard chew 8 12-hour efficacy None 8 24-hour efficacy NexGard chew 8 24-hour efficacy For all flea counts, the groups treated with NexGard had significantly lower flea counts than untreated control dogs in Study 1 (P.3) and Study 2 (P.6) Day 7 Day 14 Day 21 Day 28 Day 35 Flea Infestation Day *Percent efficacy = [(C T)/C], where T and C are the geometric mean flea counts of treated and control groups, respectively. 99.9% Study 1 Study 2 Percent Efficacy* of NexGard 24 Hours After Flea Infestation According to flea counts at 24 hours after infestation, NexGard efficacy was through Day 35 in both studies, except for one time point (99.9% on Day 21 in Study 2). SIGNIFICANCE With new flea infestations, NexGard kills the majority of adult fleas within 12 hours and provides efficacy at 24 hours post-infestation throughout the monthly treatment period. 18 skin, diarrhea, lethargy, and lack of appetite. Use with caution in dogs with a history of seizures. 19

11 NexGard Kills Fleas Before They Can Lay Eggs All Month Immature flea stages account for the vast majority of any flea infestation. 22 Flea eggs can be difficult to eliminate because they can lodge deep in carpeting, upholstery, or floor cracks and crevices. An effective flea adulticide kills fleas before they can contaminate the environment with eggs. For the egg counts at 12 hours after infestation, no flea eggs were found on Days 7, 28, and 35, resulting in efficacy. A single flea egg was collected from each of two dogs on Day 14, resulting in 99.1% efficacy, and a single flea egg was collected from one dog on Day 21, resulting in 99.5% efficacy. Treatment Group In a study,,21 flea egg counts were performed to evaluate the efficacy of orally administered NexGard in the prevention of flea egg production with repeated infestations of adult C. felis on dogs. Study Design Thirty-two healthy beagles of either sex (22 males and females) older than 12 months and weighing 9.1 to 19.1 kg were randomly assigned to the groups listed in the table at left. Number of Dogs All dogs were infested with ± 5 unfed C. felis fleas on Day 1. Treated dogs were administered a NexGard chew on Day to achieve a minimum afoxolaner dose of 2.5 mg/kg of body weight. Dogs were not fed before treatment. All dogs were repeatedly reinfested with unfed fleas on Days 7, 14, 21, 28, and 35. To facilitate flea egg collection, the waste pans below the cages were cleaned and the pans were lined with paper. In Groups 1 and 2, shed flea eggs were collected and counted at 12 hours ± 3 minutes post-infestation. In Groups 3 and 4, eggs were collected and counted at 24 hours ± 1 hour post-infestation. Egg counts were performed on Days, 1, 7, 8, 14, 15, 21, 22, 28, 29, 35, and 36 according to count-by-time block assignments in each group. Results Assessment 1: None 8 12-hour flea egg efficacy 2: NexGard chew 8 12-hour flea egg efficacy 3: None 8 24-hour flea egg efficacy 4: NexGard chew 8 24-hour flea egg efficacy For all flea egg counts, the groups treated with NexGard had significantly lower flea egg counts than untreated control dogs (P<.28) % 99.5% Day 7 Day 14 Day 21 Day 28 Day 35 Flea Infestation Day 99.8% Day 7 Day 14 Day 21 Day 28 Day 35 Flea Infestation Day Percent Efficacy* in Flea Egg Reduction at 12 Hours After Infestation for Dogs Treated With NexGard Percent Efficacy* in Flea Egg Reduction at 24 Hours After Infestation for Dogs Treated With NexGard *Percent efficacy = [(C T)/C], where T and C are the geometric mean flea egg counts of the treated and control groups, respectively. Geometric Mean and Range of C. felis Flea Egg Counts, 24 Hours After Treatment Days After Treatment Control Group Geometric Mean (Range) NexGard Group Geometric Mean (Range) For egg counts performed 24 hours after infestation, no flea eggs were found on any day, resulting in efficacy, with the exception of Day 14, when a single flea egg was collected on one dog, resulting in 99.8% efficacy at that time point (11 141). () (8 133).1 ( 1) (11 8). () SIGNIFICANCE NexGard kills fleas before they can lay eggs, reducing environmental contamination and preventing subsequent flea infestations (7 69). () (1 124). () skin, diarrhea, lethargy, and lack of appetite. Use with caution in dogs with a history of seizures. 21

12 In a Field Study, NexGard Was Effective at Killing Adult Fleas on Client-Owned Dogs Field studies demonstrate how a flea product works in the real world, where dogs may be exposed to newly emerged fleas from environments contaminated with flea eggs, larvae, and pupae. A 9-day, multicenter, clinical field study was conducted to evaluate the safety and efficacy of NexGard chews. The blinded, positive-control study used a randomized block design based on order of household enrollment. The efficacy component of this study, which focused on activity against fleas in a single sentinel (index) dog in each household, is described below. Although tick counts were performed, the number of dogs with ticks was too low to assess tick efficacy. The safety portion of this study, which included the index dogs as well as all treated dogs in the households, can be found on page 32. Efficacy Assessment Study Design A total of 282 index dogs from 282 households were enrolled at veterinary clinics in 14 sites across the United States. Participating households were selected based on the following inclusion criteria: Ownership of healthy dog(s) with up to five dogs and cats in the household. At least one dog in the household had to harbor fleas and was designated the index dog. In households where more than one dog had at least fleas, the index dog was randomly selected. For each study site, blocks of three households were formed based on order of enrollment. Within blocks, households were assigned to the treatment groups listed in the table below. Treatments were dispensed at the veterinary clinics on Visit 1 (Day ), Visit 2 ( Day 3), and Visit 3 ( Day 6). Owners were instructed to administer the treatment within 4 days of the visit. In each household: All dogs were treated with NexGard or an oral active control product. All cats were treated with a topical flea tick product. On Days, 3, 6, and 9, index dogs were evaluated at the veterinary clinics for ectoparasites: Flea counts were performed by systematically using a fine-toothed flea comb for at least 5 minutes. Live fleas and ticks were removed, counted, and recorded. Results At the start of the trial, initial flea counts on dogs subsequently treated with NexGard averaged From baseline (Visit 1, pretreatment), NexGard-treated dogs showed a significant reduction in fleas at all visits (P<.1): There was a 98% effectiveness in reduction in fleas 1 month after the first treatment, 99.7% effectiveness after Month 2, and 99.9% effectiveness after Month 3. SIGNIFICANCE In households with existing flea infestations of varying severity, NexGard reduced fleas by 98.% to 99.9% over the course of 3 monthly treatments. Study Group Number of Dogs Treatment NexGard chew 2 96 Oral active control product % 99.7% 99.9% Visit 2 Visit 3 Visit 4 Percent Reduction in Fleas for NexGard Treatment Group, Geometric Mean 22 skin, diarrhea, lethargy, and lack of appetite. Use with caution in dogs with a history of seizures. 23

13 Tick Expansion: Puts Dogs at Greater Risk Because ticks are expanding into new geographic areas, veterinary practitioners may encounter infectious diseases that were once uncommon in the area. Today, ticks pose a greater threat to dogs across the country than ever before. 23 Several tick species are following the growing population of white-tailed deer, their preferred hosts, into new areas. Other wildlife hosts, such as coyotes, raccoons, wild turkeys, and even feral cats and dogs are moving into suburban and urban areas, bringing ticks with them. And in many areas, climate fluctuations are extending the tick season. All of this adds up to more ticks, distributed across a broader geographic range, often with prolonged tick questing activity, putting canine patients at greater risk of tick-borne diseases. Dogs May Be Co-infected With Multiple Pathogens Ticks can transmit a wide range of bacterial, rickettsial, viral, protozoan, and fungal organisms. 24 To complicate matters, ticks can be co-infected with multiple infectious microbes, and dogs can also be infested with more than one species of tick; this means canine patients are at increased risk of becoming infected with multiple tick-borne pathogens. 23 Ticks of Veterinary Importance May Be Infected With More Than One Pathogen Vector Organism or Agent Disease Ixodes scapularis (black-legged tick) Dermacentor variabilis (American dog tick) Amblyomma americanum (Lone star tick) Borrelia burgdorferi 25,26 Anaplasma phagocytophilum 27 Rickettsia rickettsii 26,28 Ehrlichia canis 29,3 * Ehrlichia chaffeensis 3,31 Salivary neurotoxins 26 Ehrlichia ewingii 26,27 Ehrlichia chaffeensis 26,27 Salivary neurotoxins 26 Possibly Rickettsia rickettsii 26 *Experimental infections have been documented with this vector. Lyme disease Anaplasmosis Rocky Mountain spotted fever Ehrlichiosis Tick paralysis Ehrlichiosis Tick paralysis Rocky Mountain spotted fever Canine Tick-Borne Diseases and Their Clinical Signs The growing list of tick-borne infections that can harm dogs in the United States includes: Lyme disease (borreliosis) 25 Fever, lameness, joint swelling, or lymphadenomegaly may be the only signs in the early stages of this disease. Lyme disease can also be subclinical. Infection has been associated with a severe and fatal form of protein-losing glomerulonephritis. Rocky Mountain spotted fever 28 The short incubation period of this disease (2 to 14 days) means clinical signs, such as fever and edema of the extremities, lips, pinnae, and scrotum, can occur relatively soon after transmission. Petechial or ecchymotic hemorrhage are also common findings. Lab results often reveal thrombocytopenia. Ehrlichiosis 3 Subtle signs, such as anorexia, bleeding diatheses, fever, lethargy, and lymphadenomegaly, are common with this disease. Dogs may then enter into a subclinical stage, and show no outward signs, but exhibit thrombocytopenia on laboratory analysis. In the chronic stages, impaired bone marrow production may lead to pancytopenia and a poor prognosis. Anaplasmosis 23,27 The causative agent for anaplasmosis is transmitted by the same ticks that carry the pathogen for Lyme disease. The result is that dogs may be co-infected with both A. phagocytophilum and B. burgdorferi. Similar to other tick-borne diseases, signs of anaplasmosis may include anorexia, fever, lameness, and lethargy. Thrombocytopenia may also occur. Tick paralysis 26 Salivary neurotoxins from feeding female ticks cause tick paralysis. The first clinical signs are weakness and hindlimb incoordination, followed by paralysis in the forelimbs, neck, and respiratory muscles. Once ticks are removed, affected dogs will usually recover. Co-infection with more than one tickborne pathogen can complicate the clinical presentation and make diagnosis more difficult. With the expansion of ticks into more places, veterinarians should be on the lookout for signs of tick-borne diseases in their patients

14 NexGard Kills Three Common Tick Species Six studies with a total of 8 dogs were conducted to evaluate the efficacy of NexGard against three species of ticks of veterinary importance in the United States (Ixodes scapularis, Dermacentor variabilis, and Amblyomma americanum). The FDA Center for Veterinary Medicine requires at least two studies demonstrating effectiveness against each species of tick. Study Design Although each study used a single species of tick, all studies followed the same randomized block design. In each study, 16 to beagles ranging from 6.1 to 46.2 months of age were randomly assigned to two groups, as shown in the table. Results: Ixodes scapularis 32,33 NexGard was 94.2% effective against live I. scapularis ticks through Day 3. Live tick counts were significantly reduced (P.2 and P<.1 for Studies 1 and 2, respectively), and dead tick counts were significantly increased (P.1 and P.7 for Studies 1 and 2, respectively) in the treated group compared to the control group at all time points. Study Group Number of Dogs Treatment 1 (Control) 8 to None 2 8 to NexGard chew On Day 1, all dogs were infested with 5 unfed adult ticks. On Day, dogs in Group 2 were administered a NexGard chew to achieve a minimum afoxolaner dose of 2.5 mg/kg of body weight. Percent Efficacy Against Ixodes scapularis 48 Hours After Treatment or Reinfestation All dogs were reinfested with 5 ticks on Days 7, 14, 21, and 28. Forty-eight hours after treatment, live and dead ticks were collected from all dogs. After re-infestation on Days 7, 14, 21, and 28, live and dead ticks were removed and counted from individual animals at 48 hours after infestation in the I. scapularis and D. variabilis studies. In the A. americanum studies, live and dead ticks were removed and counted from individual animals at 72 hours after infestation. Percent effectiveness of the treated group with respect to the control group was based on live tick counts on the animals and was calculated using the formula [(C T)/C] x, where C = geometric mean of live ticks on the control group dogs and T = geometric mean of live ticks on the treated group dogs for each time point. Dead ticks in the collection pans under the cages were counted and removed 24 and 48 hours after treatment in all studies. After infestation on Days 7, 14, 21, and 28, dead ticks were counted and removed from collection pans 24 and 48 hours after infestation (I. scapularis and D. variabilis studies) or 24, 48, and 72 hours after infestation (A. americanum studies) % * 98.5% 99.1% Day 2 Day 9 Day 16 Day 23 Day 3 Study 1 Study 2 *A minimum of 25% of the original ticks used to infest the animal at each time point evaluated was considered to be an adequate infestation, and a minimum of six adequately infested control dogs was required for the study to be considered valid. These conditions were not met for the tick infestations on Day 7 of Study 1 and Day 21 of Study % 99.6% * 94.2% 98.% 26 skin, diarrhea, lethargy, and lack of appetite. Use with caution in dogs with a history of seizures. 27

15 Results: Dermacentor variabilis 34 NexGard was 97.3% effective against live D. variabilis ticks through Day 3. There were significant differences in live tick counts (P.6) and dead tick counts (P.2) between treated and control dogs at all time points. Results: Amblyomma americanum 32 NexGard was effective against live adult A. americanum ticks when measured 48 hours after treatment and was 97.8% effective when measured at 72 hours post-infestation for 31 days. Live tick counts were significantly reduced (P.1) and dead tick counts were significantly increased (P.18) in the treated group compared to the control group at all time points. Percent Efficacy Against Dermacentor variabilis 48 Hours After Treatment or Infestation Percent Efficacy Against Amblyomma americanum 48 Hours After Treatment and 72 Hours After Infestation % 99.7% 97.3% 98.5% Day 2 Day 9 Day 16 Day 23 Day % 98.9% 97.8% Day 2 Day Day 17 Day 24 Day 31 Study 1 Study 2 Study 1 Study 2 SIGNIFICANCE The increased number of dead ticks and the reduction of live ticks across all studies support the treatment and control indications of NexGard for black-legged ticks (I. scapularis), American dog ticks (D. variabilis), and Lone star ticks (A. americanum). 28 skin, diarrhea, lethargy, and lack of appetite. Use with caution in dogs with a history of seizures. 29

16 Afoxolaner: A novel molecule for veterinary use, has undergone extensive safety testing Initial Probe Studies Demonstrated the Safety of Afoxolaner in Dogs Before developing the final formulation of NexGard, numerous probe studies 4 were conducted with an experimental oral solution of afoxolaner designed to provide high bioavailability and accurate dosing. During the entire length of the study, all dogs were evaluated by veterinary physical exams, weight, and serum chemistry and hematology, as well as clinical observations for adverse reactions. In initial safety studies, 35 oral administration of 25 mg/kg afoxolaner every other week for 3 months resulted in no clinically significant effects. Toxicology studies 35 with afoxolaner in dogs demonstrated no clinically relevant effects following two oral doses of mg/kg. A 5-month in vivo study 4 also evaluated the safety of the test compound when administered to dogs at an afoxolaner dose of 2.5 mg/kg at 3-day intervals. No clinical signs of adverse reactions were observed during the study. Group means for hematology and serum chemistry parameters were within normal limits. Weight variation was minimal, with no discernable difference between the afoxolaner-treated group and the control group. SIGNIFICANCE These findings confirmed the potential for afoxolaner as a safe ectoparasiticide for dogs and led the way to additional target animal safety studies. In a Margin of Safety Study, NexGard Was Demonstrated to Be Well Tolerated in Dogs as Young as 8 Weeks of Age A 4.5-month in vivo study 36 was conducted to evaluate the safety of afoxolaner formulated as a soft, beef-flavored chew in dogs. Study Design F 3 C F 3 C CI Thirty-two healthy puppies (16 males and 16 females) 8 to 9 weeks of age were randomly allocated into four groups. Dogs were dosed at 1, 3, and 5 multiples of the highest afoxolaner exposure level for the product weight ranges (6.3 mg/kg). All dogs were observed for general health twice daily beginning on at least Day 14. Feed consumption was monitored daily beginning on Day 1. O N Treatments were administered at: 4-week dose intervals through Day 84 (Days, 28, 56, and 84) Followed by 2-week intervals (Days 98 and 112) Physical examinations including body weights were performed three times pretreatment and biweekly throughout the study period. Blood for clinical pathology analysis was collected twice pretreatment and biweekly throughout the study period. Urine for urinalysis examination was collected once pretreatment and on Days 27 and 126. H O All dogs were weighed and humanely euthanized, and a full necropsy with tissue collection was performed 2 weeks after the last treatment (Day 126). Results Throughout the study, no clinically or statistically significant abnormalities related to the administration of NexGard were observed. At all sampling periods, no afoxolaner-related changes were observed in: Daily food consumption Body weight Physical examination variables Hematology parameters N N O H Vomiting and diarrhea were observed sporadically across all groups, including the controls. There were no afoxolaner-related changes in: Gross observation at necropsy H&E-stained microscopic tissue sections Terminal body or organ weights SIGNIFICANCE Study Group Number of Dogs Treatment 1 (Control) 8 Sham dosing NexGard was demonstrated to be well tolerated in dogs as young as 8 weeks of age. Chew administered orally to achieve a minimum afoxolaner dose of 6.3 mg/kg of body weight Chew administered orally to achieve a minimum afoxolaner dose of 18.9 mg/kg of body weight* Chew administered orally to achieve a minimum afoxolaner dose of 31.5 mg/kg of body weight* *Because of the large dose volume, doses were divided into two approximately equal portions and administered 3 hours apart. On treatment days, dogs were observed for 4 hours after the second administration. Coagulation profiles Urinalysis parameters Plasma chemistry values CF 3 3 skin, diarrhea, lethargy, and lack of appetite. Use with caution in dogs with a history of seizures. 31

17 Multicenter Field Study Confirmed the Safety of NexGard in Client-Owned Dogs A 9-day, multicenter, clinical field study was conducted to evaluate the safety and efficacy of NexGard. Study Design The basic design of this study is described under the field efficacy study listed on page 22. In this well-controlled U.S. field study, which included a total of 333 households and 615 treated dogs (415 administered afoxolaner; administered active control), no serious adverse reactions were observed with NexGard. Over the 9-day study period, all observations of potential adverse reactions were recorded by the 15 veterinary clinics that completed the study. Results The most frequent reactions reported at an incidence of >1% within any of the 3 months of observations are presented in the table on the next page. The most frequently reported adverse reaction was vomiting. The occurrence of vomiting was generally self-limiting, of short duration, and tended to decrease with subsequent doses in both groups. Five treated dogs experienced anorexia during the study, and two of those dogs experienced anorexia with the first dose but not subsequent doses. Two dogs with a history of seizures experienced seizures during the study. 32 Any health abnormalities observed in the dogs treated with NexGard were regarded as mild. There was a similar prevalence of abnormal health observations reported for both the NexGard and oral active control product groups, with the exception of emesis. The prevalence of emesis in dogs treated with the oral active control product was 3 times higher than those treated with NexGard and was 4 times higher on the day of treatment. Dogs With Adverse Reactions Treatment Group Afoxolaner Oral active control product N1 % (n=415) N2 % (n=) Vomiting (with and without blood) Dry/flaky skin Diarrhea (with and without blood) Lethargy Both NexGard and the oral active Anorexia control product were administered 1 Number of dogs in the afoxolaner treatment group with the identified abnormality. 2 in conjunction with anthelmintics, Number of dogs in the control group with the identified abnormality. antibiotics, vaccines, steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and other frequently used veterinary products. Concurrent medications administered during the study did not appear to impact the safety or efficacy of NexGard. SIGNIFICANCE NexGard has been demonstrated to be safe in dogs when administered by pet owners at the recommended dose over a 3-month period. skin, diarrhea, lethargy, and lack of appetite. Use with caution in dogs with a history of seizures. 33

18 NexGard: Product Composition and Packaging NexGard: Administration Product Composition Each NexGard chew is formulated to provide a minimum afoxolaner dosage of 2.5 mg/kg (1.14 mg/lb). Each chew contains 2.27% w/w of afoxolaner. NexGard Dosing and Administration Body Weight of Dog NexGard 1.14 mg/lb (2.5 mg/kg) Minimum Dose Chew Size (g) Quantity of Afoxolaner (mg) lbs Chew Sizes NexGard is available in four flavored chew sizes:.5 g 1.25 g 3 g 6 g (11.3 mg afoxolaner) (28.3 mg afoxolaner) (68 mg afoxolaner) (136 mg afoxolaner) Small to. Medium Large Extra Large Administer the appropriate combination of chewables Over 121. Frequency of Administration and Directions for Use NexGard is given orally once a month at the minimum dosage of 1.14 mg/lb (2.5 mg/kg). Packaging Each chew is packaged individually in a foil-backed blister card that contains one, three, or six chews. To remove a chew from the foil-backed blister, peel back the foil, starting at the arrow in the corner, as shown below. To give NexGard, first remove a chew from the foil-backed blister card by peeling back the foil from the inner corner, as shown by the arrow. The pack is designed so that the foil must be peeled back in three steps. NexGard can be administered with or without food. Care should be taken that the dog consumes the complete dose, and treated animals should be observed for a few minutes to ensure that part of the dose is not lost or refused. If it is suspected that any of the dose has been lost or if vomiting occurs within 2 hours of administration, redose with another full dose. If a dose is missed, administer NexGard and resume a monthly dosing schedule

19 Each chewable size is available in color-coded packages of three or six chews. Small For dogs 4. to. lbs Package Insert Large For dogs 24.1 to 6. lbs CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Description: NEXGARD (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). Afoxolaner has the chemical composition 1-Naphthalenecarboxamide, 4-[5- [3-chloro-5(trifluoromethyl)-phenyl]-4, 5-dihydro-5-(trifluoromethyl)-3-isoxazolyl]-N-[2-oxo-2-[(2,2,2trifluoroethyl)amino]ethyl. Indications: NEXGARD kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of Black-legged tick (Ixodes scapularis), American Dog tick (Dermacentor variabilis), and Lone Star tick (Amblyomma americanum) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for one month. Dosage and Administration: NEXGARD is given orally once a month, at the minimum dosage of 1.14 mg/lb (2.5 mg/kg). Dosing Schedule: Medium For dogs.1 to 24. lbs Body Weight Extra Large For dogs 6.1 to 121. lbs 4. to. lbs..1 to 24. lbs to 6. lbs. 6.1 to 121. lbs. Over 121. lbs. Afoxolaner Per Chewable (mg) Chewables Administered 11.3 One 28.3 One 68 One 136 One Administer the appropriate combination of chewables NEXGARD can be administered with or without food. Care should be taken that the dog consumes the complete dose, and treated animals should be observed for a few minutes to ensure that part of the dose is not lost or refused. If it is suspected that any of the dose has been lost or if vomiting occurs within two hours of administration, redose with another full dose. If a dose is missed, administer NEXGARD and resume a monthly dosing schedule. Flea Treatment and Prevention: Treatment with NEXGARD may begin at any time of the year. In areas where fleas are common year-round, monthly treatment with NEXGARD should continue the entire year without interruption. To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product. Tick Treatment and Control: Treatment with NEXGARD may begin at any time of the year (see Effectiveness). For dogs over 121. lbs, administer the appropriate combination of chewables. Back Panel Contraindications: There are no known contraindications for the use of NEXGARD. Warnings: Not for use in humans. Keep this and all drugs out of the reach of children. In case of accidental ingestion, contact a physician immediately. Precautions: The safe use of NEXGARD in breeding, pregnant or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures (see Adverse Reactions). Adverse Reactions: In a well-controlled US field study, which included a total of 333 households and 615 treated dogs (415 administered afoxolaner; administered active control), no serious adverse reactions were observed with NEXGARD. Over the 9-day study period, all observations of potential adverse reactions were recorded. The most frequent reactions reported at an incidence of > 1% within any of the three months of observations are presented in the following table. The most frequently reported adverse reaction was vomiting. The occurrence of vomiting was generally selflimiting and of short duration and tended to decrease with subsequent doses in both groups. Five treated dogs experienced anorexia during the study, and two of those dogs experienced anorexia with the first dose but not subsequent doses. Table 1: Dogs With Adverse Reactions. Oral active control N2 % (n=) Vomiting (with and without blood) Dry/Flaky Skin Diarrhea (with and without blood) Lethargy Anorexia Number of dogs in the afoxolaner treatment group with the identified abnormality. Number of dogs in the control group with the identified abnormality Afoxolaner % (n=415) To report suspected adverse events, for technical assistance or to obtain a copy of the MSDS, contact Merial at or For additional information about adverse drug experience reporting for animal drugs, contact FDA at FDA-VETS or online at Mode of Action: Afoxolaner is a member of the isoxazoline family, shown to bind at a binding site to inhibit insect and acarine ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. Prolonged afoxolanerinduced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. The selective toxicity of afoxolaner between insects and acarines and mammals may be inferred by the differential sensitivity of the insects and acarines GABA receptors versus mammalian GABA receptors. Effectiveness: In a well-controlled laboratory study, NEXGARD began to kill fleas four hours after initial administration and demonstrated >99% effectiveness at eight hours. In a separate well-controlled laboratory study, NEXGARD demonstrated effectiveness against adult fleas 24 hours post-infestation for 35 days, and was 93% effective at 12 hours post-infestation through Day 21, and on Day 35. On Day 28, NEXGARD was 81.1% effective 12 hours post-infestation. Dogs in both the treated and control groups that were infested with fleas on Day -1 generated flea eggs at 12and 24-hours post-treatment (-11 eggs and 1-17 eggs in the NEXGARD treated dogs, and 4-9 eggs and -118 eggs in the control dogs, at 12- and 24-hours, respectively). At subsequent evaluations post-infestation, fleas from dogs in the treated group were essentially unable to produce any eggs (-1 eggs) while fleas from dogs in the control group continued to produce eggs (1-141 eggs). In a 9-day US field study conducted in households with existing flea infestations of varying severity, the effectiveness of NEXGARD against fleas on the Day 3, 6 and 9 visits compared with baseline was 98.%, 99.7%, and 99.9%, respectively. Collectively, the data from the three studies (two laboratory and one field) demonstrate that NEXGARD kills fleas before they can lay eggs, thus preventing subsequent flea infestations after the start of treatment of existing flea infestations. In well-controlled laboratory studies, NEXGARD demonstrated >94% effectiveness against Dermacentor variabilis and Ixodes scapularis, 48 hours post-infestation, and against Amblyomma americanum 72 hours post-infestation, for 3 days. Animal Safety: In a margin of safety study, NEXGARD was administered orally to 8- to 9-week-old Beagle puppies at 1, 3, and 5 times the maximum exposure dose (6.3 mg/kg) for three treatments every 28 days, followed by three treatments every 14 days, for a total of six treatments. Dogs in the control group were sham-dosed. There were no clinicallyrelevant effects related to treatment on physical examination, body weight, food consumption, clinical pathology (hematology, clinical chemistries, or coagulation tests), gross pathology, histopathology or organ weights. Vomiting occurred throughout the study, with a similar incidence in the treated and control groups, including one dog in the 5x group that vomited four hours after treatment. In a well-controlled field study, NEXGARD was used concomitantly with other medications, such as vaccines, anthelmintics, antibiotics (including topicals), steroids, NSAIDS, anesthetics, and antihistamines. No adverse reactions were observed from the concomitant use of NEXGARD with other medications. Storage Information: Store at or below 3 C (86 F) with excursions permitted up to 4 C (4 F). How Supplied: NEXGARD is available in four sizes of beef-flavored soft chewables: 11.3, 28.3, 68 or 136 mg afoxolaner. Each chewable size is available in color-coded packages of 1, 3 or 6 beef-flavored chewables. NADA , Approved by FDA Treatment Group N1 In the US field study, one dog with a history of seizures experienced a seizure on the same day after receiving the first dose and on the same day after receiving the second dose of NEXGARD. This dog experienced a third seizure one week after receiving the third dose. The dog remained enrolled and completed the study. Another dog with a history of seizures had a seizure 19 days after the third dose of NEXGARD. The dog remained enrolled and completed the study. A third dog with a history of seizures received NEXGARD and experienced no seizures throughout the study. Marketed by: Frontline Vet Labs, a Division of Merial Limited. Duluth, GA USA Made in Brazil Rev. 4/14 NexGard and FRONTLINE VET LABS are trademarks of Merial. 14 Merial. All rights reserved. 37

20 References 1. NexGard package insert. Merial, Limited. 2. Data on file. Merial, Limited. 3. Letendre L, Huang R, Kvaternick V, et al. The intravenous and oral pharmacokinetics of afoxolaner, a novel isoxazoline, used as a monthly chewable antiparasitic for dogs. Vet Parasitol 14;1: Shoop WL, Hartline EJ, Gould BR, et al. Discovery and mode of action of afoxolaner, a new isoxazoline parasiticide for dogs. Vet Parasitol 14;1: Thoms C, Ebel R, Proksch P. Sequestration and possible role of dietary alkaloids in the spongefeeding mollusk Tylodina perversa. In: Cimino G, Gavagnin M, eds. Molluscs: From Chemo-ecological Study to Biotechnological Application. Progress in Molecular and Subcellular Biology series. Marine Molecular Biotechnology subseries. Vol. 43. Berlin: Springer; 6: Lahm GP, Cordova D, Barry JD, et al. 4-Azolylphenyl isoxazoline insecticides acting at the GABA gated chloride channel. Bioorg Med Chem Lett 13;23: Habeeb AG, Praveen Rao PN, Knaus EE. Design and synthesis of 4,5-diphenyl-4-isoxazolines: novel inhibitors of cyclooxygenase-2 with analgesic and antiinflammatory activity. J Med Chem 1;44: Antczak C, Bauvois B, Monneret C, Florent JC. A new acivicin prodrug designed for tumor-targeted delivery. Bioorg Med Chem 1;9: Imran M, Khan SA, Siddiqui N. Therapeutic potential of 2-isoxazolines. Ind J Pharm Sci 4;66: Data on file. Merial, Limited. 11. Data on file. Merial, Limited 12. Data on file. Merial, Limited. 13. García-Reynaga P, Zhao C, Sarpong R, Casida JE. New GABA/glutamate receptor target for [ 3 H] isoxazoline insecticide. Chem Res Toxicol. 13 Mar. [Epub ahead of print]. 14. Buckingham SD, Biggin PC, Sattelle BM, et al. Insect GABA receptors: splicing, editing, and targeting by antiparasitics and insecticides. Mol Pharmacol 5;68: Data on file. Merial, Limited. 16. Dryden MW. Flea and tick control in the 21st century: challenges and opportunities. Vet Dermatol 9;: Dryden MW, Rust MK. The cat flea: biology, ecology and control. Vet Parasitol 1994;52: Dryden MW. Host association, on-host longevity and egg production of Ctenocephalides felis felis. Vet Parasitol 1989;34: Freedom of Information Summary, supplemental NADA , NEXGARD, April 1, 14.. Freedom of Information Summary, NADA , NEXGARD. 21. Hunter JS 3rd, Dumont P, Chester TS, et al. Evaluation of the curative and preventive efficacy of a single oral administration of afoxolaner against cat flea (Ctenocephalides felis) infestations on dogs. Vet Parasitol 14;1: Rust MK, Dryden MW. The biology, ecology, and management of the cat flea. Annu Rev Entomol 1997;42: Bowman D, Little SE, Lorentzen L, et al. Prevalence and geographic distribution of Dirofilaria immitis, Borrelia burgdorferi, Ehrlichia canis, and Anaplasma phagocytophilum in dogs in the United States: results of a national clinic-based serologic survey. Vet Parasitol 9;16: Nicholson WL, Sonenshine DE, Lane RS, Uilenberg G. Ticks (Ixodida). In: Mullen GR, Durden LA, eds. Medical and Veterinary Entomology. 2nd ed. Burlington, MA: Academic Press, Elsevier; 9: Greene CE, Straubinger RK, Levy SA. Borreliosis. In: Greene CE, ed. Infectious Diseases of the Dog and Cat. 4th ed. St. Louis: Saunders Elsevier; 12: Bowman DD. Arthropods. In: Bowman DD, ed. Georgis Parasitology for Veterinarians. 9th ed. Missouri: Saunders Elsevier; 9: Diniz PP, Breitschwerdt EB. Anaplasma phagocytophilum infection (canine granulocytotropic anaplasmosis). In: Greene CE, ed. Infectious Diseases of the Dog and Cat. 4th ed. St. Louis: Saunders Elsevier; 6: Greene CE, Kidd L, Breitschwerdt EB. Rocky Mountain and Mediterranean spotted fevers, cat-flea typhuslike illness, rickettsialpox and typhus. In: Greene CE, ed. Infectious Diseases of the Dog and Cat. 4th ed. St. Louis: Saunders Elsevier; 12: Johnson EM, Ewing SA, Barker RW, et al. Experimental transmission of Ehrlichia canis (Rickettsiales: Ehrlichieae) by Dermacentor variabilis (Acari: Ixodidae). Vet Parasitol 1998;74: Harrus S, Waner T, Neer TM. Ehrlichia canis infection. In: Greene CE, ed. Infectious Diseases of the Dog and Cat. 4th ed. St. Louis: Saunders Elsevier; 12: Harrus S, Waner T, Neer TM. Ehrlichia chaffeensis infection (human monocytotropic ehrlichiosis). In: Greene CE, ed. Infectious Diseases of the Dog and Cat. 4th ed. St. Louis: Saunders Elsevier; 12: Freedom of Information Summary, supplemental NADA , NEXGARD, May 15, Mitchell EB, McCall JW, Chester T, et al. Efficacy of afoxolaner against Ixodes scapularis ticks in dogs. Vet Parasitol 14;1: Mitchell EB, Dorr P, Everett WR, et al. Efficacy of afoxolaner against Dermacentor variabilis ticks in dogs. Vet Parasitol 14;1: Data on file. Merial, Limited. 36. Drag M, Saik J, Harriman J, Larsen D. Safety evaluation of orally administered afoxolaner in 8-week-old dogs. Vet Parasitol 14;1:

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