| Summary: | The safety profile of NexGard® Combo, a novel topical product for cats combining esafoxolaner, eprinomectin and praziquantel, for the treatment and prevention of internal and external parasites, was evaluated in kittens, in two margin-of-safety studies (Studies #1 and #2), and in an oral tolerance study (Study #3). In the margin of safety studies, kittens were dosed several times topically with multiples of the maximum exposure dose (1×): in Study #1, 3× and 5× doses four times at 2-week intervals; in Study #2, 1×, 3× and 5× doses six times at 4-week intervals. In Study #3, kittens were dosed orally once with a 1× dose. Furthermore, in Study #1, another group of kittens was dosed topically twice at a 4-week interval with a formulation of esafoxolaner as the sole active ingredient dosed at 23×. Physical examinations and clinical pathology analyses were performed throughout the studies, followed by necropsy and detailed histopathological evaluation in Studies #1 and #2. No significant treatment related effects were observed in the three studies, except for one occurrence of reversible neurological signs attributed to eprinomectin in one cat after the third 5× dose in Study #2, with clinical signs observed nine hours after dosing, pronounced for a few hours, significantly improved the next day, and absent 2 days after dosing. In conclusion, NexGard® Combo was demonstrated safe in kittens following repeated topical administrations and following oral ingestion, and very high topical doses of esafoxolaner were well tolerated.
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