Combination drug approved as canine sedative

A product recently approved for use in dogs combines a sedative with a drug to reduce the risk of harmful cardiovascular side effects.

On March 30, the Food and Drug Administration approved the combination of medatomidine and vatinoxan hydrochloride, to be sold under the trade name Zenalpha, as a sedative and analgesic for administration by injection to dogs to aid examinations, clinical procedures, and minor surgical procedures. The drug sponsor is Finland-based Vetcare Oy.

FDA information notes that medatomidine, which is a sedative with analgesic properties, was already approved for administration to dogs and is in the same drug class as dexmedetomidine. But medatomidine can cause a decrease in a dog’s heart rate and increase the risk of arrythmias. Vatinoxan, which was not previously approved, keeps a dog’s heart rate closer to its normal range.

An FDA summary document indicates dogs administered Zenalpha in a field effectiveness study had faster onset of sedation and faster recovery time in comparison with dogs administered dexmedetomidine. Dogs that received Zenalpha also had smaller declines in heart rates and body temperatures.

Diarrhea, muscle tremors, and colitis were the most common adverse reactions, FDA information states.