Elanco’s ZORBIUM™ (Buprenorphine Transdermal Solution) – the First Long-Acting Transdermal Buprenorphine for Cats - Gains U.S. Approval

Rhea-AI Summary

The FDA has approved Zorbium, a new transdermal solution for managing postoperative pain in cats, marking a significant expansion of Elanco's pain management portfolio. This long-acting medication offers up to four days of postoperative pain control from a single dose, reducing the burden on pet owners for at-home medication administration. Anticipated to launch mid-year 2022, Zorbium underscores Elanco's commitment to innovation in veterinary pain relief, addressing an unmet market need.

Positive

• FDA approval of Zorbium enhances Elanco's pain management offerings.
• Zorbium provides up to four days of postoperative pain control from a single dose.
• Innovative transdermal application eases administration for pet owners.

Negative

• Potential risks of misuse, abuse, and addiction associated with the opioid in Zorbium.
• Life-threatening side effects can occur from accidental exposure.

FDA issues approval for new, prescription medication to control postoperative pain associated with surgical procedures in cats, expanding Elanco’s pain portfolio.

GREENFIELD, Ind.--(BUSINESS WIRE)-- With the U.S. Food and Drug Administration (FDA) approval of Zorbium™ (buprenorphine transdermal solution), Elanco Animal Health (NYSE: ELAN) expands its pain management offerings while addressing an unmet need for veterinary practices.

A new long-acting medication to control postoperative pain associated with surgical procedures in cats, ZORBIUM provides up to four days of pain control from a single transdermal dose. ZORBIUM is an innovative, transdermal formulation of a commonly used opioid (buprenorphine) in cats, enabling veterinarians to provide consistent, reliable pain relief to their post-op feline patients for 4 days without relying upon owners to administer an opioid after discharge and without the need for repeat injections. Consistent pain control reassures cat owners and reduces the challenges of administering pain medications at home.

“The simplification of dosing helps limits the movement of opioids, which can give clinics and pet parents alike peace of mind,” said Dr. Ellen de Brabander, executive vice president of Innovation and Regulatory Affairs at Elanco “The needleless transdermal application is met with sustained pain control, avoiding the potential for missed doses associated with repeat dosing protocols.”

Elanco’s first new product approval of 2022, Zorbium™ is anticipated to reach the U.S. veterinary community mid-year.

ZORBIUM represents an important milestone in the continued diversification of Elanco’s portfolio and pipeline. Last month, Elanco announced measures to transform and simplify its R&D organization to narrow focus and concentrate investments on accelerating delivery of the late-stage Pet Health pipeline.

“Elanco has long been an innovation leader in pain management in pets, and this approval is a perfect example of Elanco’s capabilities meeting the science and the market need,” de Brabander said.

ZORBIUM™ joins Elanco’s growing therapeutic portfolio, which includes solutions in the areas of pain management, internal medicine, oncology and dermatology. For more information about Elanco’s cat health portfolio, visit https://www.elanco.us/products-services/cats.

INDICATION: Zorbium is indicated for the control of postoperative pain associated with surgical procedures in cats.

IMPORTANT SAFETY INFORMATION: Before using ZORBIUM (buprenorphine transdermal solution), read the entire package insert including the Boxed Human Warning. Call 1-888-545-5973 for full prescribing information.

ZORBIUM contains buprenorphine, an opioid that exposes humans to risks of misuse, abuse, and addiction, which can lead to overdose and death. Use of buprenorphine may lead to physical dependence. The risk of abuse by humans should be considered when storing, administering, and disposing of ZORBIUM.

Serious, life-threatening, or fatal respiratory depression may occur with accidental exposure to or with misuse or abuse of ZORBIUM. ZORBIUM should only be administered by veterinarians or veterinarian technicians who are trained in the handling of potent opioids. Accidental exposure to even one tube of ZORBIUM, especially in children, can result in a fatal overdose.

ZORBIUM is for topical application in cats only. Do not come into direct contact with ZORBIUM. Wear impermeable latex or nitrile gloves, protective glasses and a laboratory coat when applying ZORBIUM. Following application to the cat, allow a minimum drying time of 30 minutes before direct contact with the application site.

Do not administer to cats with a known hypersensitivity to buprenorphine hydrochloride, any inactive ingredients of ZORBIUM, or known intolerance to opioids. Do not apply ZORBIUM 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.

Body temperature should be monitored postoperatively. Most common adverse reactions during anesthesia were hypothermia, hypotension, and hypertension, and after anesthetic recovery were hypothermia, hyperthermia, and sedation.

The safe use of ZORBIUM has not been evaluated in debilitated cats, those with renal, hepatic, cardiac or respiratory disease, pregnant lactating, breeding, in cats younger than four months old or <2.6 lbs or > 16.5 lbs.

ABOUT ELANCO

Elanco Animal Health Incorporated (NYSE:ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including but not limited to statements about Zorbium, its potential benefits, approvals in the U.S., and anticipated product availability. These forward-looking statements are based on Elanco’s current expectations and assumptions and are subject to change. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. These include, but are not limited to, the risks and uncertainties inherent in research and development such as launch dates, the possibility of unfavorable new clinical data and further analyses of existing clinical data, and further decisions by regulatory authorities that could impact labeling, manufacturing processes, safety and/or other matters. For further discussion of these and other risks and uncertainties, see Elanco’s most recent Form 10-K and subsequent Form 10-Q filings with the United States Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which reflect information only as of the date of this release. Except as required by law, Elanco undertakes no duty to update forward-looking statements contained in this release.

Zorbium, Elanco and the diagonal bar logo are trademarks of Elanco and its affiliates.
© 2022 Elanco or its affiliates. PM-US-21-3418

View source version on businesswire.com: https://www.businesswire.com/news/home/20220120005920/en/

Media Contact: Keri S. McGrath +1.317.370.8394 mcgrath_happeks@elanco.com

Investor Contact: Katy Grissom (317) 273-9248 kathryn.grissom@elancoah.com

Source: Elanco Animal Health Incorporated

FAQ

What is Zorbium and what is it used for?

Zorbium is a transdermal solution approved by the FDA for controlling postoperative pain in cats.

When will Zorbium be available in the U.S.?

Zorbium is expected to reach the U.S. veterinary community by mid-year 2022.

What are the benefits of Zorbium for cats?

Zorbium offers up to four days of pain relief from a single dose, reducing the challenges of at-home medication administration.

What are the safety concerns associated with Zorbium?

Zorbium carries risks of misuse, abuse, and potential life-threatening respiratory depression from accidental exposure.

How does Zorbium fit into Elanco's product portfolio?

Zorbium represents a significant addition to Elanco's growing therapeutic portfolio in pain management.