| Summary: | 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. Conclusion 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.
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