The efficacy and safety of a novel isoxazoline parasiticide, sarolaner (Simparica (TM)), for the control of fleas on dogs was evaluated in a randomized, controlled clinical study conducted in 19 general veterinary practices throughout the United States. Four hundred and seventy nine (479) dogs from 293 households were enrolled. Each household was randomly assigned to treatment with either sarolaner oral tablets (Simparica (TM), Zoetis) at the proposed label dose or an approved comparator product at the label dose (spinosad, Comfortis (R), Elanco). Dogs were dosed by their owners at home on Day 0 and on approximately Days 30 and 60. Dogs were examined at the clinics for general health, flea and tick infestation, and clinical signs of flea allergy dermatitis (FAD) at the initial visit and Days 14, 30, 60 and 90. Blood was collected for clinical pathology at screening and Day 90. Sarolaner was well-accepted by dogs with the majority of flavored chewable tablets (91.5%) accepted free choice, by hand or in food. Geometric mean live flea counts were reduced by >99% at the first time measured (14 days) after initiation of treatment and continued to reduce through the study. Treatment success (proportion of dogs with >= 90% reduction in fleas) for the sarolaner-treated dogs was superior to that for spinosad-treated dogs at Days 14 and 30 and non-inferior on Days 60 and 90 (P <= 0.025) The rapid reduction in flea infestations resulted in a similar rapid resolution of the clinical signs associated with FAD. Sarolaner chewable tablets were well tolerated with no treatment related adverse reactions. Most of the clinical signs reported were consistent with allergies and dermatitis or sporadic occurrences of conditions commonly observed in the general dog population. A wide variety of concomitant medications, including many commercially available heartworm preventatives and other anthelmintic drugs, were administered to study dogs and all were well tolerated. Sarolaner administered orally to provide a minimum dosage of 2.0 mg/kg (range 2-4 mg/kg) once monthly for three consecutive treatments was safe and effective in the treatment and prevention of natural infestations of fleas and resulted in a substantial improvement of clinical signs associated with FAD. (C) 2016 Published by Elsevier B.V.
