FDA Approves Pregabalin Oral Solution for Alleviating Anxiety Associated with Transportation and Veterinary Visits in Cats

November 17, 2023

Today the U.S. Food and Drug Administration approved Bonqat (pregabalin oral solution) for the alleviation of acute anxiety and fear associated with transportation and veterinary visits in cats. The drug is administered orally approximately 1.5 hours before the start of the transportation or veterinary visit and can be given on two consecutive days. Bonqat is the first FDA-approved animal drug containing pregabalin.

The sponsor conducted a field study in client-owned cats with a history of anxiety and/or fear when transported by car and during veterinary visits. The study included two separate visits over the course of 5 to 10 days that included transportation and physical examinations for each cat. The first visit was a screening visit prior to treatment to enroll the cat in the study. The second visit was following treatment with Bonqat or placebo to evaluate the effectiveness of Bonqat. The cat owner assessed their cat’s anxiety and/or fear when transported in a car, and the veterinarian assessed the cat’s anxiety and/or fear during a physical examination at the veterinary clinic. A little over half of cats given Bonqat had a good to excellent response during both transportation and the veterinary visit compared to about one-third of cats given placebo. In addition, 83 of 108 (77%) cats given Bonqat showed improvement in levels of fear and anxiety over the course of the two physical examinations, compared to 46 of 101 (46%) cats given placebo. Adverse reactions related to Bonqat included mild sedation, ataxia, and lethargy.

Bonqat is only available by prescription from a licensed veterinarian because it is a DEA Schedule Class V drug with a potential for human abuse. In addition, professional expertise is required to monitor the safe use of the product, including proper dosing and administration.

The labeling for Bonqat contains information about drug abuse, addiction, and diversion. In addition, appropriate precautions should be taken while handling Bonqat, including avoiding contact with a person’s skin, eyes, and other mucus membranes. 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 Bonqat contains 50 mg pregabalin. Bonqat is packed 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).

Bonqat is administered orally as a single dose of 5 mg/kg (0.1mL/kg) approximately 1.5 hours before the start of the transportation or veterinary visit.

Bonqat is sponsored by Orion Corp. based in Espoo, Finland.

100ml PP vaccine vial

250ml PE plastic vaccine bottle

Source from FDA: https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-pregabalin-oral-solution-alleviating-anxiety-associated-transportation-and-veterinary