Abstract
NexGard® Combo, a novel topical endectoparasiticide product for cats, is a combination of esafoxolaner, eprinomectin and praziquantel. The safety of this novel combination administered to females during reproduction and lactation was evaluated per analysis of breeding parameters and adverse reactions observed on females and offspring. Females with successful breeding history were randomized to three groups, a placebo group and groups treated with the novel formulation at 1× or 3× multiples of the maximum exposure dose. Females were dosed at 28-day intervals, at least twice before mating, then during a period including mating, pregnancy, whelping and 56 days of lactation. In the placebo, 1× and 3× groups, 10, 9 and 10 females, respectively completed the study (nine, seven and nine females achieved pregnancy), and were dosed 7.1 times on average. Breeding parameters included success of mating, success of gestation, length of gestation, abortion rate, number of live, dead and stillborn kittens at birth, number of kittens with abnormalities, weight of kittens after birth and at weaning, growth of kittens, proportion of male and female kittens, and proportion of kittens born alive and weaned. No significant adverse reactions related to the novel combination were observed on females and on kittens; no significant and adverse effects on breeding parameters were observed.
Highlights
NexGardÒ Combo, a novel endectoparasiticide topical product for cats, is a combination of esafoxolaner, eprinomectin and praziquantel, aimed at the control of infestations by arthropods, and the treatment of infections by nematodes and cestodes, respectively
The target animal safety of this novel product was evaluated in three studies designed in accordance with the requirements of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products, VICH Guideline 43 [27], and which demonstrated safety of NexGardÒ Combo in kittens following repeated topical administrations at 1X, 3X and 5X, and following oral ingestion at 1X the maximum exposure [12]
The potential effects of repeated administrations of NexGardÒ Combo in reproducing female cats, on breeding parameters, as well as on their offspring were investigated in a specific safety study, described in this manuscript
Summary
NexGardÒ Combo, a novel endectoparasiticide topical product for cats, is a combination of esafoxolaner, eprinomectin and praziquantel, aimed at the control of infestations by arthropods, and the treatment of infections by nematodes and cestodes, respectively. Afoxolaner has been used safely for years in oral acaricide and insecticide products for dogs (NexGardÒ and NexGard SPECTRAÒ, BoehringerIngelheim). Eprinomectin and praziquantel are both wellknown compounds in veterinary medicine and in cats [6, 7, 13, 14, 20, 24], with many years of safe and effective use. The target animal safety of this novel product was evaluated in three studies designed in accordance with the requirements of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products, VICH Guideline 43 [27], and which demonstrated safety of NexGardÒ Combo in kittens following repeated topical administrations at 1X, 3X and 5X, and following oral ingestion at 1X the maximum exposure [12].
Sign-in/Register to view highlights & summary 
Published Version (
Free)
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call