FDA issues approval for new, prescription medication to control
postoperative pain associated with surgical procedures in cats,
expanding Elanco’s pain portfolio.
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
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Media Contact: Keri S. McGrath +1.317.370.8394
mcgrath_happeks@elanco.com Investor Contact: Katy Grissom (317)
273-9248 kathryn.grissom@elancoah.com
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