FDA approves expanded indication for sarolaner, moxidectin, and pyrantel chewable tablets

Officials with the FDA have approved a new label indication for sarolaner, moxidectin, and pyrantel chewable tablets (Simparica Trio; Zoetis) for the prevention of Borrelia burgdorferi infections in dogs aged 8 weeks and older weighing at least 2.8 pounds. The treatment works by killing Ixodes scapularis vector ticks, including black-legged or deer ticks, that can transmit the infection. Sarolaner, moxidectin, and pyrantel chewable tablets is the first combination product demonstrated to prevent infections that may cause Lyme disease, according to Zoetis.¹

The combination drug's expanded use is the first new indication since the treatment's approval in early 2020, and it is particularly significant as ticks are a threat year-round, according to Zoetis.¹

The label expansion includes approval for the treatment and control of immature stages (L4 and immature adult) for hookworm. Sarolaner, moxidectin, and pyrantel chewable tablets are also approved for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and hookworm (L4 and adult Ancylostoma caninum and adult Uncinaria stenocephala) infections. Treatment and control of immature and adult roundworms and hookworms help reduce environmental contamination from worm eggs and lowers the risk of infection in dogs, according to Zoetis.¹

Lyme disease is 1 of the most common tick-borne illnesses transmitted to dogs and data shows that it is a growing threat to dogs in the United States, according to Zoetis. In 2020, one in 20 dogs across the United States tested positive for Lyme infection.²

Signs of Lyme disease in dogs include lameness, enlarged lymph nodes, fever, lack of appetite and lethargy. In some cases, it can also lead to kidney failure. It is also possible for a dog to be infected with the disease and not show clinical signs, according to Zoetis.¹

“Once dogs are infected with Borrelia burgdorferi, the bacteria’s unique mode of motility allows it to rapidly disseminate throughout the body. This can make the infection difficult to treat,” said Richard T. Marconi, PhD, an expert in microbiology and immunology at Virginia Commonwealth University Medical Center and a consultant for Zoetis. “The most important thing we can do is to prevent infection in the first place using a comprehensive strategy that includes the use of an effective tick preventative product and vaccination.”

Use of sarolaner, moxidectin, and pyrantel chewable tablets is cautioned in dogs with a history of seizures. Sarolaner is a member of the isoxazoline class, which 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 these tablets has not been evaluated in breeding, pregnant, or lactating dogs. The most frequently reported adverse reactions in clinical trials were vomiting and diarrhea, according to Zoetis.¹

References

1. Zoetis Announces FDA Approval of Simparica Trio® (sarolaner, moxidectin, and pyrantel chewable tablets) NewLabel Indication for Prevention of Borrelia burgdorferi Infections in Dogs. News release. Zoetis. January 4, 2022.
2. CAPC: Parasite Prevalence Maps Canine Lyme Disease USA 2020. https://capcvet.org/maps/#/2020/all-year/lyme-disease/dog/united-states. Accessed January 4, 2022.