Agency Continues to Support Development of
Overdose Reversal Drugs including Naloxone and Nalmefene
SILVER
SPRING, Md., Aug. 7, 2024
/PRNewswire/ -- Today, the U.S. Food and Drug Administration
approved Zurnai, the first nalmefene hydrochloride auto-injector
for the emergency treatment of known or suspected opioid overdose
in adults and pediatric patients 12 years of age and older. The
agency approved the first nasal spray formulation of nalmefene in
May 2023.
Drug overdose persists as a major public health issue in the
U.S., with more than 107,000 reported fatal overdoses occurring in
2023, primarily driven by synthetic opioids like illicit fentanyl.
Nalmefene and naloxone are two available options to reverse opioid
overdose. The FDA has worked to increase availability and
accessibility of both options to encourage harm reduction and
reduce overdose death.
"The FDA remains focused on broadening access to opioid
overdose reversal agents, including naloxone and nalmefene. Today's
approval adds a new nalmefene product and route of administration
to support greater options for opioid overdose reversal," said FDA
Commissioner Robert M. Califf, M.D.
"Since launching the FDA Overdose Prevention Framework in 2022, the
agency continues to build upon efforts that address the overdose
crisis currently impacting the nation."
Nalmefene is an opioid receptor antagonist which is used to
treat acute opioid overdose. If nalmefene is administered quickly,
it can reverse the effects of opioid overdose, including
respiratory depression, sedation and low blood pressure
(hypotension). The newly approved product delivers 1.5 milligrams
(mg) of nalmefene under the skin (subcutaneous) or into muscle
(intramuscular). Zurnai is a single-dose, pre-filled auto-injector
and is available only by prescription.
The approval of Zurnai is supported by safety and
pharmacokinetic studies, as well as a study in healthy individuals
who use opioids recreationally, to assess how quickly the product
works. The most common adverse reactions are feeling hot,
dizziness, nausea, headache, chills, vomiting, feeling pain from
actions that aren't typically painful such as lightly touching your
skin (allodynia), palpitations, ringing or buzzing in the ear
(tinnitus), ear discomfort, feeling abnormal, burning sensation,
hot flush and irritability.
The use of nalmefene hydrochloride in patients who are
opioid-dependent may result in opioid withdrawal characterized by
the following signs and symptoms: body aches, diarrhea, fast heart
rate (tachycardia), fever, runny nose, sneezing, goosebumps
(piloerection), sweating, yawning, nausea or vomiting, nervousness,
restlessness or irritability, shivering or trembling, abdominal
cramps, weakness and increased blood pressure.
The FDA granted this application Fast Track and Priority
Review designations, which expedite the development and review of
drugs that have the potential to provide a significant improvement
in the safety or effectiveness of the treatment, diagnosis or
prevention of a serious condition.
The FDA granted approval of Zurnai to Purdue Pharma L.P.
The FDA's Overdose Prevention Framework is the agency's
vision to undertake impactful, creative actions to prevent drug
overdoses and reduce deaths. The framework consists of four
priorities, including encouraging harm reduction through efforts to
increase availability of and expand access to overdose reversal
products.
Additional Resources:
- FDA Overdose Prevention Framework
- Information about Naloxone and Nalmefene
- Timeline of Selected FDA Activities and Significant Events
Addressing Opioid Misuse and Abuse
# # #
Media Contact: Lauren-Jei
McCarthy, 240-702-3940
Consumer Inquiries: Email, 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration