Novel therapy for treating anxiety and fear in cats receives FDA approval

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Officials with the FDA have approved pregabalin oral solution (Bonqat; Orion Corp.) for alleviating acute anxiety and fear associated with transportation and veterinary visits in cats. This therapy is the first for use in animals containing pregabalin to receive the FDA’s approval.

Available only by prescription from a veterinarian, pregabalin oral solution is a DEA Schedule Class V drug because of its potential for misuse by humans. It is indicated for administration as a single dose of 5 mg/kg (0.1mL/kg) approximately 1.5 hours before the start of the transportation or veterinary visit and can be given on 2 consecutive days.

A field study in client-owned cats with a history of anxiety and/or fear when transported by car and during veterinary visits was conducted by Orion Corp., based in Espoo, Finland. The study included 2 visits over the course of 5 to 10 days that included transportation and physical examinations for each cat. The first visit focused on screening prior to treatment, for study enrollment. The second visit followed treatment with pregabalin oral solution or a placebo to evaluate the effectiveness of the studied drug.

Cat owners assessed their pets’ anxiety and/or fear when transported in a car, and the veterinarian assessed these feline’s anxiety and/or fear during a physical examination at the veterinary clinic. A little more than half of cats given pregabalin oral solution had a good-to-excellent response during both transportation and the veterinary visit compared to about one-third of cats given placebo. Additionally, 77% of cats given the drug showed improvement in levels of fear and anxiety over the course of the 2 physical examinations, compared to 46% of cats that were administered the placebo. Adverse reactions related to pregabalin oral solution included mild sedation, ataxia, and lethargy.

The labeling for the FDA-approved pregabalin oral solution contains information about drug misuse, addiction, and diversion. Additionally, appropriate precautions should be taken while handling pregabalin oral solution, including avoiding contact with a person’s skin, eyes, and other mucus membranes, according to the FDA. People exposed to pregabalin should seek medical advice and may experience dizziness, sleepiness, blurred vision, weakness, dry mouth, and difficulty with concentration or attention.

Each mL of pregabalin oral solution contains 50 mg pregabalin. The therapy is distributed in a clear glass bottle containing 2 mL of dosing solution with a child resistant closure and adapter. The bottle is further packed into a carton with a package insert, client information sheet, and an oral syringe (1 mL).

Reference

FDA approves pregabalin oral solution for alleviating anxiety associated with transportation and veterinary visits in cats. News release. FDA. November 17, 2023. Accessed November 17, 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-pregabalin-oral-solution-alleviating-anxiety-associated-transportation-and-veterinary?utm_medium=email&utm_source=govdelivery