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

Nadja Rohdich,Eva Zschiesche,Rainer Ka Roepke

doi:10.1186/1756-3305-7-83

Abstract

BackgroundFluralaner, a new molecular entity of the isoxazoline class, has potent insecticidal and acaricidal activity and can be safely administered orally to dogs.MethodsA 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.ResultsAt 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.ConclusionsBravecto™ (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.

Highlights

Fluralaner, a new molecular entity of the isoxazoline class, has potent insecticidal and acaricidal activity and can be safely administered orally to dogs
This study presents results of a rigorous, Good Clinical Practice (GCP) compliant, blinded field study comparing BravectoTM with a positive control under typical veterinary practice conditions
Dogs were ineligible if the household included a severely ill animal requiring intensive veterinary care, any dog who had received previous ectoparasiticide treatment within the previous 7 to 30 days depending on the expected duration of effect of the treatment, a pregnant or lactating female dog, more than 5 dogs, or other pet species that could harbor fleas and/or ticks sharing the same resting area; if insecticide or insect growth regulator had been applied in the household environment within the previous two months; or if the dog would need to spend substantial time at a dog sitter or animal shelter during the study period

Summary

Introduction

Fluralaner, a new molecular entity of the isoxazoline class, has potent insecticidal and acaricidal activity and can be safely administered orally to dogs. Veterinarians and animal owners are looking for more effective and longer lasting treatments to include in their ectoparasite control protocols They have concerns about the irritation and injury caused directly by fleas and ticks and the risks these parasites introduce as infectious-disease vectors. In vitro testing determined that fluralaner is a highly potent arthropod-specific GABA-gated chloride channel inhibitor, with a less potent, but still significant, inhibitory activity on arthropod glutamate-gated chloride channels and its receptor binding was 5–236 fold better than fipronil on arthropod GABA-gated chloride channels [5]. This receptor potency difference could translate into improved efficacy for fluralaner over fipronil for ectoparasite control under field conditions

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