FDA expands labels for 3 parasite prevention and treatment therapies

Photo: AK ST/Adobe Stock

Haemaphysalis longicornis or Asian longhorned tick

New label indications for several parasiticide therapies have been approved by the FDA. The agency has expanded uses for Zoetis’ sarolaner, moxidectin, and pyrantel chewable tablets (Simparica Trio); sarolaner (Simparica Chewables), and selamectin and sarolaner topical solution (Revolution Plus), according to the company.¹

Combination chewable tablets

Sarolaner, moxidectin, and pyrantel combination tablets are newly indicated for the treatment and control of Asian longhorned tick (Haemaphysalis longicornis) infestations in canines aged 8 weeks or older and weighing 2.8 lbs or more.¹ This tick species is not native to Western Hemisphere and was first reported in the US in 2017.^2,3

“Ticks pose a significant health risk to pets. Ensuring readily available and efficient tick control options is crucial to safeguarding pets' health, ultimately enabling them to enjoy more quality time with their owners,” Mason Reichard, PhD, field parasitologist at Zoetis, said in a news release.¹ “Expanding the efficacy claim of Simparica Trio to include treatment and control of infestations of the Asian longhorned tick offers veterinarians a valuable resource to combat this invasive tick species and gives dog owners peace of mind.”

Sarolaner, moxidectin, and pyrantel combination tablets were previously approved to prevent heartworm disease caused by Dirofilaria immitis, treat and control certain roundworm (Toxocara canis; adult Toxascaris leonine) and certain hookworm (Ancylostoma caninum; adult Uncinaria stenocephala) infections, and to kill adult fleas (Ctenocephalides felis) infestations and prevent and treat their infestations. It is also approved by the FDA for treating and controlling several types of tick infestations. It is also indicated for prevention of Borrelia burgdorferi infections by killing vector ticks.²

The FDA has determined sarolaner, moxidectin, and pyrantel combination tablets to be safe and effective, based on data submitted by Zoetis. According to the agency, 2 safety studies have now demonstrated the efficacy of sarolaner, moxidectin, and pyrantel combination tablets against Asian longhorned ticks in dogs. Both studies showed the combination drug was equal or greater than 99.6% effective at controlling these infestations.²

A seizure was reported in 1 dog during one of the 2 studies.² Zoetis is cautioning use of this combination drug in dogs with a history of seizures.¹

Sarolaner chewables

Sarolaner chewables received a label expansion for the treatment of Asian longhorned tick infestations in dogs ages 6 months and older at a weight of 2.8 lbs or more. The FDA determined safe and effective use for this new use when administered as the label indicates.^1,3

According to the FDA, sarolaner chewables were previously approved by the agency for killing adult fleas, and treating and preventing their infestations; treating and controlling infestations of the lone star tick (Amblyomma americanum), Gulf Coast tick (Amblyomma maculatum), American dog tick (Dermacentor variabilis), black-legged tick (Ixodes scapularis), and brown dog tick (Rhipicephalus sanguineus); and preventing Borrelia burgdorferi infections by killing black-legged vector ticks.³

A pair of studies demonstrated that sarolaner chewables are effective against Asian longhorned tick infestations in dogs 6 months of age or older. In each study, enrolled canines were experimentally infested with viable, unfed, adult Asian longhorned ticks and administered sarolaner chewables or a control tablet. Periodic tick counts in both studies showed sarolaner chewables was greater than 99% effective at controlling Asian longhorned tick infestations for 1 month, while dogs in the control group remained infested with live ticks at each tick count. The drug was also shown to be effective at treating Asian longhorned tick infestations by increasing the number of dead ticks, for which treated dogs had a higher number than the control group, for 1 month. Neither study had reported adverse reactions.³

Selamectin and sarolaner topical solution

Approval for the prevention of tapeworm (Dipylidium caninum) infections as a direct result of killing vector fleas was granted by the FDA for expansion of the label for selamectin and sarolaner topical solution. This new indication is for 1 month use in cats and kittens aged 8 weeks and older, and weighing 2.8 lbs or more.^1,4

The topical solution previously received FDA approval for managing various parasite infestations in cats and kittens. These indications include prevention of heartworm disease; treatment and control of certain roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections; treatment and control of ear mite (Otodectes cynotis) infestations; killing adult fleas; treatment and prevention of flea infestations; and treatment and control of infestations with lone star tick, Gulf Coast tick, American dog tick, and black-legged tick.⁴

Officials with the FDA have determined selamectin and sarolaner topical solution to be safe and effective for cats, based on data submitted by Zoetis. The company conducted 2 studies that show efficacy in preventing tapeworm infection in cats, according to the FDA. Results of these studies demonstrated the topical solution was more than 94% effective in killing adult fleas and greater than 97% effective at preventing flea infections.⁴

Although no adverse events were reported in these 2 recent studies, earlier clinical trials reported adverse effects with the use of selamectin and sarolaner topical solution that included lethargy and anorexia. Zoetis also recommends using the product with caution in felines with a history of neurologic disorders.^1,4

References

1. Zoetis reinforces its commitment to innovation and leadership in parasiticides with its latest FDA approvals broadening protection for dogs and cats. News release. Zoetis. January 14, 2025. Accessed January 14, 2025. https://www.zoetisus.com/news-and-media/zoetis-reinforces-its-commitment-to-innovation-and-leadership
2. FOI summary for the supplemental approval of new animal drug application 141-521. FDA. November 6, 2024. Accessed January 14, 2025. https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16065
3. FOI summary for the supplemental approval of new animal drug application 141-452. FDA. November 22, 2024. Accessed January 14, 2025. https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16325
4. FOI summary for the supplemental approval of new animal drug application 141-502. FDA. November 13, 2024. Accessed January 14, 2025. https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16247