Chewable tablet for controlling pruritus in dogs is approved by the FDA

Photo courtesy of Zoetis.

Officials with the FDA have approved oclacitinib chewable tablets (Apoquel Chewable; Zoetis) for the control of pruritus associated with allergic dermatitis and atopic dermatitis in dogs aged 1 year or older. According to Zoetis, this tablet is the first chewable treatment for the control of allergic itch and inflammation in dogs available in the United States. It is expected to have comparable efficacy to oclacitinib tablets (Apoquel; Zoetis)—available for the past 10 years—after the first dose, and a formulation that may improve medication compliance and outcomes for dogs.¹

Pruritus is the most common sign of allergies in dogs, and atopic dermatitis affects up to 15% of the canine population.² Itching caused by environmental allergies can be an acute, short-term condition or can be recurrent, seasonal or chronic. The skin disease can impact the quality of life for both the dog and owner, according to a Zoetis news release.¹

In a study, 65% of pet owners reported challenges in giving their dogs tablet-based treatments.³ With the approval of oclacitinib chewable tablets, pet owners will have a new treatment option to help enhance medication compliance as well as maintaining the human-animal bond by making daily dosing less stressful.¹

“Veterinarians and pet owners prefer chewable options–in a study, 56% of pet owners would choose a chewable over an injection or a tablet–and we believe that this, combined with the high palatability of a flavored chewable tablet, will lead to increased compliance, so that pet owners can spend more quality time with their dogs,” said Andy Hillier, BVSc, MANZCVS (Canine Medicine), DACVD, director of dermatology medical strategy and field specialists at Zoetis, in the release.¹

Palatability Field Trial Results

In the US field trial, 1662 doses of oclacitinib chewable tablets were administered to 120 pet dogs. These tablets were administered twice daily for up to 14 days at the labeled dose range of 0.4–0.6 mg/kg with palatability assessed for the first 7 days of dosing. The study found that 91.6% of the doses were accepted voluntarily within 5 minutes, according to Zoetis.¹

“As a veterinarian, I often hear from frustrated pet owners who report that their dog resists accepting an unflavored tablet, even when it is hidden inside of food or if the dog previously took the pill, which can have a significant impact on the quality of life for dogs living with atopic dermatitis,” said Ashley Bourgeois, DVM, and board-certified veterinary dermatologist, in the Zoetis release.¹ “The availability of a flavored chewable tablet is a major step forward for many pet owners in that it is expected to provide comparable efficacy to the original tablet after the first dose, but in a palatable formulation.”

Release

1. Zoetis announces FDA approval of Apoquel Chewable (oclacitinib chewable tablet) for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs. News release. Zoetis. June 13, 2023. Accessed June 13, 2023. https://news.zoetis.com/press-releases/press-release-details/2023/Zoetis-Announces-FDA-Approval-of-Apoquel-Chewable-oclacitinib-chewable-tablet-for-Control-of-Pruritus-Associated-With-Allergic-Dermatitis-and-Control-of-Atopic-Dermatitis-in-Dogs/default.aspx
2. Hillier A, Griffin CE. The ACVD task force on canine atopic dermatitis (I): incidence and prevalence. Vet Immunol Immunopathol. 2001; 81(3-4): 147-151.
3. Data on File, TI-08796. ZMR: Adelphi/PROVE: Pet Owner Preferences Chewable Vs. Conventional Canine Pruritus, ZoetisServices LLC, September 2022.