BRAVECTO® Clinical Studies
Published Clinical Studies
View and download recent clinical studies to stay up-to-date and educated on the proven difference of BRAVECTO.
An assessment of canine ectoparasiticide administration compliance in the USA
Abstract Background: This study evaluated the timing of dog owner ectoparasiticide purchases to estimate administration compliance and assess the consequent impact of dose purchase gaps on the proportion of time that dogs were protected over a 12-month period. Methods: Ectoparasiticide purchase transactions over a 12-month period were evaluated for 626 US veterinary hospitals to determine dose purchase timing and identify consequent gaps between dose administration in dogs. Orally administered prescription ectoparasitic medications with active ingredients from the isoxazoline family (afoxolaner, fluralaner, lotilaner, or sarolaner) were included in the analysis. A period was calculated for each of the four isoxazoline-containing medications that represented the duration of protection provided by two doses of ectoparasiticide plus the average gap between these two doses. The maximum percentage of time possible for ectoparasiticide protection for this aggregate period was then calculated for each active ingredient. Results: Ectoparasiticide transaction records of owners were analyzed for 506,637 dogs. These showed that 43% of dog owners purchased just one dose over the 12-month period considered. If a dog owner purchased more than one dose, then the timing of their transactions could create a time gap between the completion of ectoparasite protection from the first dose and onset of protection from the subsequent purchase and administration of the second dose. Such gaps were observed in purchases made by 31–65% of dog owners, depending on the selected active ingredient and number of doses. The average gap duration between dose purchases was calculated for all possible dose combinations over 12 months of ectoparasite protection. Time gaps between the first and second doses are as follows: for sarolaner, 20.3 weeks; for afoxolaner, 12.9 weeks; for fluralaner, 12.8 weeks; and for lotilaner, 8.9 weeks. The proportion of time when protection was provided during the aggregate period between administration of the first and second doses was as follows: for fluralaner, 65%; for lotilaner, 49%; for afoxolaner, 40%; and for sarolaner, 30%. Conclusions: Dog owner ectoparasiticide purchase transactions showed that there were time gaps between doses leading to reduced ectoparasite protection. The longer re-administration interval for fluralaner, a consequence of its extended duration of activity, resulted in dog owners gaining the greatest proportion of ectoparasite protection time with this medication compared with shorter-acting monthly re-treatment medications. Keywords: Adherence, Dog, Dosing gap, Ectoparasiticide, Doses plus gap period, Purchase gap. Read more about this study here
Adherence to veterinary recommendations for ectoparasiticides purchased by cat owners in the USA
Abstract Background: Safe and effective flea and tick treatment options for cats are important in companion animal practice because of feline ectoparasite infestation prevalence and the potential for parasitic disease transmission. Retrospective cat owner purchasing transactions at United States of America (USA) veterinary clinics were obtained for three topical feline flea and tick ectoparasiticides. One medication, fluralaner, had a 12-week redosing interval, while two other medications (fipronil/s-methoprene/pyriproxyfen; imidacloprid/pyriproxyfen) were approved for monthly redosing. The annual number of doses purchased by cat owners was determined for each of the three medications and then compared between medications. The objective was to evaluate whether 12-week retreatment intervals resulted in a different duration of coverage compared to monthly treatments for ectoparasiticide products. Methods: Study results were obtained by analyzing the transactional records from a commercial database derived from veterinary practice management software. The study database consisted of cat owner purchasing records from January 2017 through June 2019 from 671 veterinary practices representing 41,630 cats. Results: Cat owners purchased an average of 1.5 doses of fluralaner per year which, based on a 12-week redosing interval, provides 4.2 months of treatment coverage. Cat owners who used monthly flea and tick medications respectively purchased 3.6 months (fipronil/s-methoprene/pyriproxyfen combination) and 2.8 months (imidacloprid/pyriproxyfen) annually of each of the two medications. Average yearly cat owner purchases of fluralaner provide a significantly longer duration of coverage than for cat owners purchasing fipronil/s-methoprene/pyriproxyfen (17% more) or imidacloprid/pyriproxyfen (50% more). Conclusions: Cat owners who obtained a flea and tick treatment with a 12-week redosing interval (fluralaner) protected their cats for up to 17% or 50% longer duration each year, respectively, compared to the duration of protection obtained by cat owners who used a medication re-dosed monthly. Cat owners should increase their duration of flea and tick coverage to come closer to achieving veterinary recommendations. Keywords: Adherence, Bravecto, Cat, Ectoparasiticide, Flea, Isoxazolines, Tick Read more about this study here
A single topical fluralaner application to cats and to dogs controls fleas for 12 weeks in a simulated home environment
Abstract Background: Fluralaner (Bravecto®, Merck Animal Health, Madison, NJ, USA) is a novel isoxazoline that provides up to 12 weeks flea and tick control when administered orally to dogs. Two assessor-blinded studies, one in dogs, the other in cats evaluated the sustained efficacy of a topical fluralaner formulation against fleas in a simulated home environment (SHE). Methods: Animals were ranked and blocked into groups of two using flea counts completed 24 hours following Ctenocephalides felis infestations placed on dogs on Day -64, and on cats on Day -36. Within blocks animals were randomized to a treatment group, 10 animals per group, one group to receive fluralaner spot-on (minimum dose rate for dogs, 25 mg/kg; for cats, 40 mg/kg), the other to be a sham-treated control. Animals were then placed into their SHE, one animal per pen or cage and then infested with 100 C. felis at weekly intervals. Dogs were infested from Day -56 through -21 and cats on Days -28 and -21. Fleas were counted and removed from each dog and cat on Day -1. Study animals were then held in clean pens/cages until treatment on Day 0. One day later, after treatment, all animals were returned to their home environment (SHE). Additional 50-flea challenges were placed on each animal on Days 22, 50 and 78. Fleas were counted and replaced on all animals on Day 1 and weekly thereafter for 12 weeks. Results: Arithmetic mean counts in control-group animals exceeded 10 fleas at all post-treatment assessments except on Days 1, 7 and 14. All control-group animals remained infested at each assessment from Day or 28 through Day 84, thereby validating the challenge methodology. Fluralaner efficacy was 100% on all occasions except for 2 fleas found on 1 dog on Day 1, and 3 fleas on 1 dog on Day 14. One flea was recovered from 1 fluralaner treated cat on Day 1. There were no treatment-related adverse events. Conclusions: A single application of a topical formulation of fluralaner is well tolerated and highly effective in the prevention of flea infestations of dogs and cats throughout the 12 weeks following treatment. Keywords: Bravecto®, Cat, Ctenocephalides felis, Dog, Efficacy, Flea, Fluralaner, Topical, Simulated home environment Read more about this study here
A randomized, blinded, controlled, multi-centered field study assessing the treatment of gastrointestinal nematode infections in cats with fluralaner plus moxidectin spot-on solution (Bravecto® Plus)
Abstract Background: A spot-on formulation containing fluralaner (280 mg/ml) plus moxidectin (14 mg/ml) (Bravecto® Plus) was developed for the treatment of nematode infections as well as providing 12 weeks of protection against insect and acarine parasites in cats. The effectiveness and safety of this product against feline gastrointestinal nematodes was assessed in naturally-infested, client-owned cats under field conditions in Albania, Bulgaria, Germany and Hungary. Methods: To be eligible for enrollment in this investigator-blinded study cats had to be at least 10 weeks-old, weigh at least 1.2 kg, be clinically healthy, and have a faecal sample testing positive for nematodes no more than eight days prior to treatment. Cats were stratified into blocks of three in order of presentation at each center and randomly allocated in a 2:1 ratio to be treated topically on Day 0 with fluralaner plus moxidectin (minimum dose rates 40 mg/kg and 2 mg/kg, respectively) or emodepside plus praziquantel (minimum dose rates 3 mg/kg and 12 mg/kg, respectively) (Profender®). Faecal samples were collected from cats prior to treatment and 14 ± 4 days later. Results: There were 182 cats randomized to the fluralaner plus moxidectin group, and 91 to the emodepside plus praziquantel group. Prior to treatment the most commonly identified nematode egg was Toxocara cati, found in 79.1 and 82.4% of cats in the fluralaner plus moxidectin and emodepside plus praziquantel groups, respectively. Eggs of Toxascaris leonina were found in 8.2 and 6.6% of cats; of hookworms in 30.8 and 24.2%; and of Capillaria spp. in 7.1 and 4.3%, respectively. After treatment, faecal samples from 98.3% of fluralaner plus moxidectin treated and 96.6% of emodepside plus praziquantel-treated cats were free of nematode ova. Geometric mean faecal egg count reductions for T. cati, the only eggs found in post-treatment faecal samples, were 99.97% and 99.93%, respectively. Treatment with fluralaner plus moxidectin was non-inferior to emodepside plus praziquantel. Both products were safe and well tolerated by cats treated under field conditions. Conclusions: This field study confirms that, in addition to 12-week extended duration flea and tick control, fluralaner plus moxidectin provides broad spectrum treatment of nematodes in cats. Keywords: Bravecto Plus, Cat, Emodepside, Field study, Fluralaner, Hookworms, Lungworms, Moxidectin, Praziquantel, Roundworms Read more about this study here
A randomized, blinded, controlled USA field study to assess the use of fluralaner topical solution in controlling feline flea infestations
Abstract Background: Fleas are a common ectoparasite of domestic cats and there is a need for novel treatments that improve feline flea control. Methods: This investigator-blinded, multi-center randomized, positive-controlled study evaluated the flea control in cats provided by a single owner-applied treatment with a fluralaner topical formulation compared with a positive control. Households with up to five healthy cats, all at least 12 weeks of age and weighing at least 1.2 kg (2.6 lb), were randomized in an approximate 3:1 ratio of fluralaner to positive control. All cats in households randomized to the positive control group were dispensed three treatments, at 4-week intervals, of a commercial formulation of fipronil/(S)-methoprene. All cats in households randomized to the fluralaner group were dispensed an initial treatment at enrollment and a second treatment at week 12 for an additional 3-week observation of treatment safety. One primary cat with at least five live fleas at enrollment was randomly selected within each household. Flea counts were performed on all primary cats at 4-week intervals through week 12. Efficacy measurement was based on reduction in flea counts from baseline. Treatment was considered effective at weeks 4, 8 and 12 if mean live flea count reductions were 90% or greater and statistically significantly different (P ≤ 0.05) from counts at enrollment. Results: In 18 investigational veterinary clinics across 11 USA states, 116 households (224 cats) were randomized to receive topical fluralaner and 45 households (87 cats) were randomized to the fipronil-methoprene combination. Fluralaner was demonstrated to be effective at 4 weeks (99.1% flea count reduction), 8 weeks (99.5%), and 12 weeks (99.0%), and all reductions were significantly different from the enrollment count (all P < 0.0001). The fipronil-methoprene combination was < 90% effective at each post-treatment assessment, with peak efficacy of 75.4% at 12 weeks (all P < 0.0001). No treatment-related serious adverse events were reported in either group. Conclusions: Owner-applied fluralaner topical treatment was safe in cats and was highly effective in killing fleas over the subsequent 12 weeks. Keywords: Bravecto, Fluralaner, Fleas, Fipronil-methoprene, Cats Read more about this study here
A randomized, blinded, controlled USA field study to assess the use of fluralaner topical solution in controlling canine flea infestations
Abstract Background: Orally administered fluralaner effectively controls fleas and ticks on dogs for 12 weeks. This study evaluates the flea control efficacy achieved with topically applied fluralaner in dogs. Methods: This investigator-blinded, multi-center randomized, positive controlled study evaluated flea control efficacy in dogs following a single owner-applied treatment of topical fluralaner. A positive control group received three treatments, at 4-week intervals, of a commercial formulation of fipronil/(S)-methoprene. All dogs in households randomized to the fluralaner group were dispensed an initial treatment at enrollment and a second treatment at week 12 for an additional 3-week observation of treatment safety. Households with up to five healthy dogs, all at least 12 weeks of age and weighing at least 2 kg (4.4 lb), were randomized in a ratio of 3:1 of fluralaner to positive control. Within households, one primary dog with at least 10 live fleas at enrollment was randomly selected. Flea counts were performed on all primary dogs every 4 weeks through week 12. Efficacy measurement was based on reduction from baseline flea counts. Treatment was considered effective if geometric mean live flea count reductions at weeks 4, 8, and 12 were 90% or greater and significantly different from counts at enrollment. In addition, for each time point the arithmetic mean live flea counts, the efficacy based on arithmetic means, the number and percentage of dogs with at least a 90% reduction in flea count, and the number and percentage of flea free dogs were calculated. Statistical comparisons were also made between treatment groups. Results: At 12 sites, across 10 states, 121 households (221 dogs) were randomized to receive fluralaner and 44 households (100 dogs) were randomized to receive the positive control. Fluralaner was demonstrated to be significantly effective (all P ≤ 0.0001) at 4 weeks (99.8% reduction), 8 weeks (99.9%), and 12 weeks (99.9%). The positive control was significantly different from baseline (all P ≤ 0.0001) and showed a reduction of 81.2% at 4 weeks and was effective at 8 weeks (90.3%) and 12 weeks (93.0%). Arithmetic mean flea count reductions for the fluralaner group at 4, 8, and 12 weeks were 99.8, 99.9, and 99.9%, respectively. For the positive control, arithmetic mean flea count reductions were 58.8, 75.3, and 80.8% at 4, 8, and 12 weeks, respectively. No treatment-related serious adverse events were reported in either group. Conclusions: Owner-applied topical fluralaner treatment was safe in dogs and provided ≥ 99.8% flea control efficacy for 12 weeks. Keywords: Bravecto, Fluralaner, Fleas, Fipronil-methoprene, Dogs Read more about this study here
A randomized, blinded, controlled USA field study to assess the use of fluralaner tablets in controlling canine flea infestations
Abstract Background: The novel isoxazoline molecule fluralaner provides 12 weeks activity against fleas and 8 to 12 weeks against tick infestations according to label claims. Methods: This blinded, multi-center study in client-owned dogs evaluated the flea control provided by a single oral fluralaner treatment (25–56 mg/kg; Bravecto™, Merck Animal Health) compared to a control group administered three oral spinosad (30 – 60 mg/kg; Comfortis®, Elanco) treatments at 4-week intervals together with an amitraz collar (9%, Preventic®, Virbac). Households were randomized (3:1 ratio) to either fluralaner (224 dogs, 118 households) or control (70 dogs, 39 households). Within households, one primary dog with at least 10 live fleas at enrollment was randomly selected for whole body flea counts every 4 weeks through Week 12; all dogs were followed for safety until Week 12. Fluralaner dogs received two additional doses at Weeks 12 and 24 for further safety and palatability observations through Week 26. Results: Geometric mean flea count reductions from baseline for the fluralaner group at Weeks 4, 8, and 12 were 99.7%, 99.8%, and 99.8%, respectively; and 96.1%, 99.5%, and 99.6% for the spinosad controls. Percentages of flea-free primary dogs at Weeks 4, 8, and 12 were 91.1%, 95.4%, and 95.3% for the fluralaner group; and 44.7%, 88.2%, and 84.4% for the controls; the differences were significant at Weeks 4 (P < 0.0001) and 12 (P = 0.0370). Improvements in veterinarian assessed flea allergy dermatitis (FAD) were observed in both groups. Fluralaner tablets were accepted free choice in over 90% of doses. The most common adverse event was vomiting, occurring in 7.1% of the fluralaner group and 14.3% of the controls. No treatment related serious adverse events were reported. Conclusions: A single treatment of dogs with the palatable fluralaner flavored chewable tablet provides a safe and effective option for 12 weeks of flea control at least equivalent to that of 3 sequential treatments with spinosad tablets. Linked to the high level of flea control was a substantial alleviation of associated signs of FAD. Keywords: Fluralaner, Fleas, Spinosad, Efficacy, Safety, Field study Read more about this study here
A randomized, blinded controlled and multi-centered field study comparing the efficacy and safety of BRAVECTO™ (fluralaner) against FRONTLINE™ (fipronil) in flea and tick-infested dogs
Abstract Background: Fluralaner, a new molecular entity of the isoxazoline class, has potent insecticidal and acaricidal activity and can be safely administered orally to dogs. Methods: A randomized, investigator-blinded, multi-centered field study compared the flea- and tick-control efficacy for dogs over a 12-week period with either a single oral dose of Bravecto™ (fluralaner) formulated as a chewable tablet or with three sequential topical Frontline™ (fipronil) treatments. Individual dogs were the experimental unit for ticks and households were the experimental unit for fleas. A total of 108 tick-infested dogs were treated with Bravecto™ (fluralaner) and 54 tick-infested dogs were treated with Frontline™ (fipronil). Dogs in 115 flea-infested households received Bravecto™ (fluralaner) and dogs in 61 flea-infested households received Frontline™ (fipronil). Flea and tick counts were conducted on all dogs at weeks 2, 4, 8, and 12 following initial treatment and efficacy was calculated as the mean percent reduction in tick or flea count at each time point compared with the mean pretreatment initiation count for each treatment group. Additionally, the percentages of tick-free and flea-free households were determined. Results: At weeks 2, 4, 8, and 12, Bravecto™ (fluralaner) flea-control efficacy in treated households was 99.2%, 99.8%, 99.8%, and 99.9% respectively, while Frontline™ (fipronil) efficacy was 94.1%, 93.0%, 96.0%, and 97.3%, respectively. Bravecto™ (fluralaner) tick-control efficacy on treated dogs at weeks 2, 4, 8, and 12 was 99.9%, 99.9%, 99.7%, and 100%, respectively, and Frontline™ (fipronil) tick efficacy was 97.6%, 93.8%, 100%, and 100%, respectively. Of dogs showing clinical flea allergy dermatitis (FAD) signs at the study start, 85.7% in the Bravecto™ (fluralaner)-treated group and 55.6% in the Frontline™ (fipronil)-treated group were evaluated at each time point as showing no clinical signs of FAD until study completion. Conclusions: Bravecto™ (fluralaner) administered once orally to dogs in a chewable tablet was highly effective for 12 weeks against fleas and ticks on privately-owned dogs and was significantly non-inferior (ticks) and superior (fleas) in comparison with topical Frontline™ (fipronil) administered 3 times sequentially. Keywords: Fleas, Ticks, Bravecto (fluralaner), Isoxazoline, Frontline™ (fipronil), Efficacy, Field study, Dog Read more about this study here
A quantitative evaluation of the extent of fluraner uptake by ticks (Ixodes ricinus, Ixodes scapularis) in fluralaner (BRAVECTO™) treated vs. untreated dogs using the parameters tick weight and coxal index
Abstract Background: Fluralaner is a new antiparasitic drug that was recently introduced as Bravecto™ chewable tablets for the treatment of tick and flea infestations in dogs. Most marketed tick products exert their effect via topical application and contact exposure to the parasite. In contrast, Bravecto™ delivers its acaricidal activity through systemic exposure. Tick exposure to fluralaner occurs after attachment to orally treated dogs, which induces a tick-killing effect within 12 h. The fast onset of killing lasts over the entire treatment interval (12 weeks) and suggests that only marginal uptake by ticks is required to induce efficacy. Three laboratory studies were conducted to quantify the extent of uptake by comparison of ticks’ weight and coxal index obtained from Bravecto™-treated and negative-control dogs. Methods: Three studies were conducted using experimental tick infestation with either Ixodes ricinus or Ixodes scapularis after oral administration of fluralaner to dogs. All studies included a treated (Bravecto™ chewable tablets, MSD Animal Health) and a negative control group. Each study had a similar design for assessing vitality and weighing of ticks collected from dogs of both groups. Additionally, in one study the coxal index (I. ricinus) was calculated as a ratio of tick’s ventral coxal gap and dorsal width of scutum. Tick weight data and coxal indices from Bravecto™-treated and negative-control groups were compared via statistical analysis. Results: Ticks collected from Bravecto™-treated dogs weighed significantly less (p ≤ 0.0108) than ticks collected from negative-control dogs, and their coxal index was also significantly lower (p < 0.0001). The difference in tick weights was demonstrated irrespective of the tick species investigated (I. ricinus, I. scapularis). At some assessments the mean tick weights of Bravecto™-treated dogs were significantly lower than those of unfed pre-infestation (baseline) ticks. The demonstrated tick-killing efficacy was in the range of 94.6 – 100 %. Conclusions: Tick weights and coxal indices confirm that a minimal uptake results in a sufficient exposure of ticks to fluralaner (Bravecto™) and consequently in a potent acaricidal effect. Keywords: Bravecto chewable tablets, Fluralaner, Dog, Tick weight, Coxal index, Ixodes ricinus, Ixodes scapularis, Efficacy Read more about this study here
Contact Us About the 12-Week* Difference
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*BRAVECTO kills fleas and prevents flea infestations. BRAVECTO (fluralaner) Chews for Dogs kills ticks (black-legged tick, American dog tick, brown dog tick, and Asian longhorned tick) for 12 weeks. BRAVECTO Chews also kills lone star ticks for 8 weeks. BRAVECTO (fluralaner topical solution) for Dogs kills ticks (black-legged tick, American dog tick, and brown dog tick) for 12 weeks and also kills lone star ticks for 8 weeks. BRAVECTO (fluralaner topical solution) for Cats kills ticks (black-legged tick and Asian longhorned tick) for 12 weeks and American dog ticks for 8 weeks.
Important Safety Information
BRAVECTO (fluralaner) Chews for Dogs: The most commonly reported adverse reactions include vomiting, lethargy, diarrhea, anorexia and pruritus. In some cases, adverse events have been reported following use in breeding females. BRAVECTO (fluralaner topical solution) for Dogs: The most commonly reported adverse reactions include vomiting, hair loss, diarrhea, lethargy, decreased appetite, and moist dermatitis/rash.
BRAVECTO Chews and Topical Solution for Dogs have not been shown to be effective for 12-weeks’ duration in puppies less than 6 months of age. BRAVECTO Chews and Topical Solution for Dogs are not effective against the lone star tick beyond 8 weeks of dosing. BRAVECTO Topical Solution for Dogs is for topical use only. Avoid oral ingestion.
BRAVECTO (fluralaner topical solution) for Cats: The most commonly reported adverse reactions include vomiting, itching, diarrhea, hair loss, decreased appetite, lethargy, and scabs/ulcerated lesions. BRAVECTO Topical Solution for Cats is not effective against American dog ticks beyond 8 weeks of dosing. BRAVECTO PLUS (fluralaner and moxidectin topical solution) for Cats: The most commonly reported adverse reactions include vomiting, hair loss, itching, diarrhea, lethargy, dry skin, elevated ALT, and hypersalivation. BRAVECTO PLUS has not been shown to be effective for 2 months in kittens less than 6 months of age. Use with caution in cats that are heartworm positive. The effectiveness of BRAVECTO PLUS to prevent heartworm disease after bathing or water immersion has not been evaluated.
BRAVECTO Topical Solution for Cats has not been shown to be effective for 12-weeks’ duration in puppies or kittens less than 6 months of age. BRAVECTO Topical Solution for Cats and BRAVECTO PLUS for Cats are for topical use only. Avoid oral ingestion. The safety of BRAVECTO Topical Solution for Cats and BRAVECTO PLUS has not been established in breeding, pregnant and lactating cats.
All BRAVECTO products contain fluralaner, which is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. Neurologic adverse reactions have been reported in cats receiving isoxazoline class drugs, even in cats without a history of neurologic disorders. Use with caution in cats with a history of neurologic disorders.
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