- The FDA has issued an Emergency Use Authorization (EUA) allowing Simparica Trio to be used to treat New World screwworm (Cochliomyia hominivorax) larval infestations in dogs and puppies.
- The authorization adds an emergency indication to Simparica Trio, which is already FDA approved for a range of heartworm, flea, tick and intestinal parasite indications in dogs.
- New World screwworm larvae feed on living tissue and can cause severe wounds, pain and potentially death if infestations are not treated.
- Zoetis also has New World screwworm-related authorizations and indications involving Dectomax and Dectomax-CA1 for certain livestock and other species.
- Veterinarians and animal owners are being urged to promptly report suspicious wounds, maggots or possible infestations to appropriate veterinary or animal health authorities.
Zoetis has received an Emergency Use Authorization from the U.S. Food and Drug Administration for Simparica Trio (sarolaner, moxidectin and pyrantel chewable tablets) to treat infestations caused by New World screwworm larvae in dogs and puppies.
The authorization expands the tools available to veterinarians as animal health officials monitor the threat posed by New World screwworm, or Cochliomyia hominivorax. The parasite’s larvae can infest wounds and feed on living tissue, potentially causing extensive tissue damage, pain and death if an affected animal is not treated.
Under the EUA, Simparica Trio can be used for the treatment of New World screwworm larval infestations, or myiasis, in dogs and puppies. Simparica Trio is not FDA approved for this specific indication; its use against New World screwworm is authorized under the emergency authorization.
“At Zoetis, our highest priority is protecting the health and well-being of animals,” said Abhay Nayak, EVP and president of U.S. Commercial Operations at Zoetis. He described the authorization as an additional tool for veterinarians responding to the parasite and said it builds on the company’s broader New World screwworm response.
Expanding a Multi-Species Response
Zoetis said the Simparica Trio authorization is part of a coordinated strategy addressing New World screwworm in both companion animals and livestock.
The company also offers Dectomax-CA1 Injectable (doramectin injection), a nonprescription conditionally approved product labeled for the prevention and treatment of New World screwworm infestations in certain cattle and for prevention of reinfestation for 21 days.
FDA has also issued an EUA covering certain uses of Dectomax and Dectomax-CA1. Those emergency uses include prevention and treatment of infestations in certain dairy cattle and prevention in swine, certain sheep, deer and horses, subject to the conditions of the authorization.
Zoetis said the combination of these products gives veterinarians and animal owners tools spanning multiple species as authorities work to prevent and respond to New World screwworm infestations.
Simparica Trio’s Existing Indications
Simparica Trio is already FDA approved as a once-monthly chewable for dogs and puppies 8 weeks of age and older weighing at least 2.8 pounds.
Its approved indications include prevention of heartworm disease; treatment and control of certain roundworm and hookworm infections; treatment and prevention of flea infestations; prevention of flea-transmitted Dipylidium caninum tapeworm infections; and treatment and control of infestations involving six tick species.
The product is also indicated for prevention of Borrelia burgdorferi infections as a direct result of killing vector black-legged ticks.
The New World screwworm indication differs from these established uses because it is being permitted through an EUA rather than a standard FDA approval. The authorization remains in effect only while the applicable emergency declaration supports its use, unless the authorization is revoked sooner.
Veterinarians Urged to Watch for Suspected Cases
Early detection and rapid treatment are important because New World screwworm larvae feed on living tissue. Zoetis encouraged pet owners who have concerns about the parasite to consult their veterinarian.
Suspicious wounds, maggots or possible infestations should be reported to a veterinarian, state animal health official or the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service.
Safety Information
Simparica Trio should be used with caution in dogs with a history of seizures. The product contains sarolaner, an isoxazoline that has been associated with neurologic adverse reactions, including tremors, ataxia and seizures, in dogs with or without a history of neurologic disorders.
The safe use of Simparica Trio has not been evaluated in breeding, pregnant or lactating dogs. Vomiting and diarrhea were the most frequently reported adverse reactions in clinical trials.
Veterinarians should consult the full prescribing information and the FDA EUA materials for complete indications, limitations, dosing and safety information when considering use of Simparica Trio.
Information sourced from the company’s press release.
