FDA approves new combination injection for sedation and pain relief in dogs

Officials with the FDA have approved medetomidine and vatinoxan hydrochlorides injection (Zenalpha; Vetcare Oy) for use as a sedative and analgesic in dogs, while undergoing certain clinical examination and procedures, and minor surgical procedures.^1,2

This is the first approval of vatinoxan by the FDA.¹

The drug product is a balanced combination of medetomidine, an alpha2-adrenoceptor agonist, andvatinoxan,anovelalpha2-adrenoceptorantagonist.² Medetomidine, a sedative with analgesic properties that has already been approved for use in dogs, can cause a decrease in an animal’s heart rate and can increase the chance of arrythmias, which can be significant in some dogs. Vatinoxan reduces the negative cardiovascular effects of medetomidine by keeping the heart rate closer to the normal range, thereby improving cardiovascular function, and improving the safety profile of medetomidine while the dog is sedated.¹

The combination injection is the first sedative to possess this unique combination of active pharmaceutical ingredients and effects, according to an organizational press release.The drug product was developed by Vetcare Oy in Finland, and Dechra will hold the marketing authorization in the United States.²

Medetomidine and vatinoxan hydrochlorides injection is anticipated to become available on the market in 2022.²

“[Medetomidine and vatinoxan hydrochlorides injection] will provide veterinarians with a novel therapeutic that is safe and effective for sedation in dogs,” said Ian Page, chief executive officer for Dechra, in an organizational press release.²

In a field efficacy trial, dogs treated with the combination injection had a shorter time to onset of sedation, shorter duration of sedation,and less cardiovascular and respiratory depression and adverse reactions compared to dogs in the control group receiving dexmedetomidine alone.² Examples of the examinations or procedures used in the field trial ranged from nail trims to diagnostic procedures to minor surgery to removal of skin masses and draining abscesses.¹

The most reported adverse effects from medetomidine and vatinoxan hydrochlorides injection include diarrhea, muscle tremors, and colitis.^1,2 Due to the pronounced cardiovascular effects of alpha2-adrenoceptoragonists, only clinically healthy dogs (American Society of Anesthesiologists [ASA] classes I and II) should be administered the drug. Dogs administered the drug should be monitored frequently during sedation for changes in heart rate, blood pressure, respiratoryrate, and body temperature. Tachycardia may occur in some dogs after recovery from sedation.²

This combination drug is supplied in 10 mL multi-dose glass vials and is only for use by a licensed veterinarian because professional expertise is required for proper dosing and administration of the product and to monitor the dog’s vital signs while sedated.¹

The labeling for medetomidineandvatinoxanhydrochlorides injection includes detailed safety information for people who handle, administer, or are exposed to the drug. The labeling also includes a note to physicians in case a person accidentally gets the drug on their skin or in their eyes, mouth, or mucous membranes, or accidentally injects themselves, according to the FDA.¹

References

1. FDA approves new combination drug for sedation in dogs. News release. March 30, 2022. Accessed April 4, 2022. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-new-combination-drug-sedation-dogs
2. Vetcare and Dechra announce the FDA approval of Zenalpha® (medetomidine and vatinoxan hydrochlorides injection). News release. Dechra. April 4, 2022. [email]