FDA Approves Simparica TRIO
The FDA has issued an Emergency Use Authorization for Simparica TRIO to treat New World Screwworm in dogs and puppies
The U.S. Food and Drug Administration has issued an Emergency Use Authorization for Simparica TRIO, a drug used to treat New World Screwworm infestations in dogs and puppies. According to Acting FDA Commissioner Kyle Diamantas, J.D., the FDA continues to authorize products to give veterinarians and pet owners multiple treatment options in case animals become infested with New World Screwworm.
Currently, most dogs in the U.S. are at low risk of New World Screwworm exposure due to their geographic location. However, dogs that live in, travel to, or return from areas where New World Screwworm infestations have been identified should be closely monitored for signs of infestation.
New World Screwworm Infestations
New World Screwworm infestations have only been detected in specific areas of Texas and New Mexico. The U.S. Department of Agriculture’s dashboard of Confirmed Detections of New World Screwworm provides up-to-date U.S. case information. Dog owners are advised to stay aware of the situation, know the signs of infestation, and have a conversation with their veterinarian if they have concerns.
Treatment Options
Simparica TRIO was approved by the FDA in 2020 for heartworm, flea, and tick-related indications in dogs and puppies. The drug contains sarolaner, moxidectin, and pyrantel, and is available only by prescription from a licensed veterinarian. Although isoxazoline products, including Simparica TRIO, are commonly used and safe for most dogs, they have been associated with neurologic adverse reactions.
Product Information
Detailed product information can be found in the Fact Sheet for Veterinarians: Emergency Use Authorization of Simparica TRIO for New World Screwworm. The FDA has concluded that Simparica TRIO may be effective in the treatment of New World Screwworm myiasis in dogs and puppies when used as authorized, and the known and potential benefits of the product outweigh its known and potential risks. Simparica TRIO is sponsored by Zoetis Inc., based in Kalamazoo, Michigan. The Emergency Use Authorization will be effective until it is revoked or the HHS Secretary terminates the declaration that the potential public health emergency presented by New World Screwworm justifies the emergency use authorization of animal drugs for New World Screwworm.
The FDA, as reported in the FDA News Release, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
