FDA approves long-acting transdermal buprenorphine for cats

Officials with the FDA have approved buprenorphine transdermal solution (Zorbium; Elanco Animal Health) for controlling postoperative pain in cats. This approval signifies an expansion of Elanco’s pain management offerings and addresses an unmet need for veterinary practices, according to the company.

Buprenorphine transdermal solution is a long-acting, topical medication indicated to control pain associated with feline surgical procedures. This solution provides up to 4 days of pain control from a single transdermal dose. Its’ formulation of buprenorphine, a commonly used opioid in cats, enables veterinarians to provide consistent, reliable pain relief to their post-op feline patients without relying upon owners to administer the medication after discharge and without the need for repeat injections.

“The simplification of dosing helps limit the movement of opioids, which can give clinics and pet parents alike peace of mind,” said Ellen de Brabander, PhD, executive vice president of innovation and regulatory affairs at Elanco, in a company press release.

“The needleless transdermal application is met with sustained pain control, avoiding the potential for missed doses associated with repeat dosing protocols," she added.

Buprenorphine transdermal solution should not be administered to cats with a known hypersensitivity to buprenorphine hydrochloride or any inactive ingredients of the medication, or known intolerance to opioids, according to Elanco. Additionally, the medication should not be applied if the application site at the dorsal cervical area has diseased or injured skin, or to anatomic areas other than the dorsal cervical area because absorption characteristics may be different.

The cat’s body temperature should be monitored postoperatively since the most common adverse reactions during anesthesia were hypothermia, hypotension, and hypertension, and after anesthetic recovery were hypothermia, hyperthermia, and sedation.

Furthermore, the safety of buprenorphine transdermal solution has not been evaluated in debilitated cats, those with renal, hepatic, cardiac or respiratory disease, pregnant lactating, breeding, in cats younger than 4 months weighing under 2.6 lbs or over 16.5 lbs.

Elanco warned in a company press release that buprenorphine exposes humans to risks of misuse, abuse, and addiction, which can lead to overdose and death. Use of this opioid may lead to physical dependence, and the risk of abuse by humans should be considered when storing, administering, and disposing of the solution. The company also cautioned that serious, life-threatening, or fatal respiratory depression may occur with accidental exposure to or with misuse or abuse of buprenorphine transdermal solution. Accidental exposure to the medication, especially in children, can result in a fatal overdose.

The solution should only be administered by veterinarians or veterinarian technicians who are trained in the handling of potent opioids. Individuals applying buprenorphine transdermal solution should wear impermeable latex or nitrile gloves, protective glasses, and a laboratory coat, according to Elanco. A minimum drying time of 30 minutes after application to the cat should be allowed before direct contact with the application site.

The company anticipates buprenorphine transdermal solution reaching the United States veterinary community in mid-2022. This medication joins Elanco’s growing therapeutic portfolio, which includes solutions in the areas of pain management, internal medicine, oncology, and dermatology.

Reference

Elanco’s ZORBIUM™ (Buprenorphine Transdermal Solution) – the First Long-Acting Transdermal Buprenorphine for Cats - Gains U.S. Approval. News release. Elanco. January 20, 2022. Accessed January 21, 2022.https://www.elanco.com/en-us/news/zorbium-for-cats-gains-us-approval