Details

Autor(en) / Beteiligte

• Drag, Marlene
• Tielemans, Eric
• Mitchell, Elizabeth
• McCall, John W.
• Targa, Norba
• Bruner, Richard
• Yoon, Stephen
• Colley, Beth
• Fankhauser, Becky

Titel

Safety of an oral combination of moxidectin, afoxolaner, and pyrantel pamoate in dogs

Ist Teil von

• Research in veterinary science, 2024-06, Vol.173, p.105271-105271, Article 105271

Ort / Verlag

England: Elsevier Ltd

Erscheinungsjahr

2024

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• NexGard®PLUS (moxidectin, afoxolaner, and pyrantel pamoate), is an oral combination product for dogs indicated for the prevention of heartworm disease, the treatment and prevention of flea and tick infestations, and the treatment of gastro-intestinal nematode infections. The safety of this product in dogs was evaluated in three studies. Study #1 was a margin-of-safety study conducted in puppies, dosed six times at 28-day intervals at 1X, 3X, or 5X multiples of the maximum exposure dose (equivalent to 24 μg/kg moxidectin, 5 mg/kg afoxolaner, and 10 mg/kg pyrantel). In Study #2, the product was administered to ABCB1-deficient collie dogs at a 1X dose twice at a 28-day interval, and at a 3X or 5X dose once. Study #3 evaluated the safety of the product at 1X and 3X doses administered three times at 4-week intervals, to dogs harboring adult Dirofilaria immitis. In the three studies, the safety was evaluated on the basis of multiple clinical observations and physical examinations, including a complete assessment of toxicity to macrocyclic lactones, and on comprehensive clinical and anatomical pathology evaluations in Study #1. No clinically significant combination product-related effects were observed in any of the three studies. No signs of macrocyclic lactone toxicity were observed in the ABCB1-deficient collie dogs. Some mild and self-resolving instances of emesis or diarrhea were occasionally observed in the 3X and 5X dosed dogs. NexGard® PLUS was demonstrated to be safe following multiple administrations in puppies, in ABCB1-deficient collie dogs, and in microfilaremic dogs infected with adult D. immitis. •An oral endectoparasiticide product for dogs combines moxidectin, afoxolaner and pyrantel pamoate.•The combination product was demonstrated safe in beagle dogs from the age of 8 weeks old, in a margin of safety study.•The combination product was demonstrated safe in ABCB1 deficient collie dogs.•The combination product was demonstrated safe in microfilaremic dogs harboring adult heartworms.