FDA approves Merial's NexGard, a chewable flea-tick preventive for dogs

Merial announced this week that the U.S. Food and Drug Administration (FDA) has approved NexGard (afoxolaner) Chewables, a prescription product designed to treat and prevent flea infestations and treat and control the American dog tick (Dermacentor variabilis) in dogs and puppies for one month.

Merial CEO Carsten Hellmann says NexGard will provide veterinarians with a new option for external parasite control. “We have leveraged expertise as well as our strength in chewable technologies to develop NexGard,” Hellmann says.

According to the company, NexGard has demonstrated excellent efficacy at a low dose and is the first and only soft beef-flavored chew approved to kill both fleas and ticks. It contains the active ingredient afoxolaner, an isoxazoline-based compound with a new and distinct mode of action.

NexGard will be a prescription-only product, Merial says. It will be available in four sizes for oral administration to dogs and puppies according to weight. Merial is planning to make NexGard available to veterinarians in time for the upcoming flea and tick season.

D. variabilis, the tick species controlled by NexGard, can transmit the organisms responsible for Rocky Mountain spotted fever (Rickettsia rickettsii), tularemia (Francella tularensis) and cytauxzoonosis (Cytauxzoon felis), according to parasitologist Michael Dryden, DVM, PhD. Dermacentor species can also cause tick paralysis.

NexGard is for use in dogs only, the company says. The most frequently reported adverse reactions include vomiting, dry or flaky skin, diarrhea, lethargy and anorexia. Its safety in pregnant, breeding or lactating dogs has not been evaluated, and veterinarians are advised to use with caution in dogs with a history of seizures.

To view the NexGard product label, click here.