STAMFORD, Conn.--(BUSINESS WIRE)--Purdue Pharma L.P. (“Purdue”) announced today that the U.S. Food and Drug Administration (FDA) approved the Company’s new drug application for the Zurnai™ (nalmefene injection) Auto-Injector. Zurnai (zur nye) is a single-dose auto-injector that delivers 1.5 mg of nalmefene hydrochloride per actuation.
Zurnai is indicated for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. Zurnai is intended for immediate administration as emergency therapy in settings where opioids may be present. Zurnai is not a substitute for emergency medical care. Zurnai is contraindicated in patients known to be hypersensitive to nalmefene hydrochloride or to any other ingredients in the product. 1
“We are pleased to gain approval of Zurnai, the nalmefene auto-injector for use by healthcare professionals or anyone in the community,” said Craig Landau, MD, President and CEO, Purdue. “Zurnai can be an important new tool to save lives in critical moments. We are committed to delivering solutions to help address the opioid overdose crisis and are working to provide Zurnai at no profit to the Company.”
Provisional data for the 12-months ending February 2024 show that approximately 90% of opioid overdose deaths were from synthetic opioids (primarily fentanyl).2 Furthermore, opioid overdose deaths among teens have more than doubled in recent years, with roughly 22 high-school-age adolescents dying each week from overdoses driven by fentanyl-laced prescription pills. 3 National Institutes of Health (NIH) supports development of stronger, longer-acting formulations of opioid antagonists to counteract high-potency synthetic opioids. 4
Zurnai provides an additional option to address overdoses caused by opioids, both prescription opioids and illicitly manufactured synthetic opioids. Zurnai contains nalmefene, the longest-acting opioid antagonist approved for opioid overdose reversal,1,5,6 in an auto-injector designed to be easy to use. It can be administered by anyone in the community, including healthcare professionals, first responders, as well as bystanders, caregivers, and family members.
Most common adverse reactions that occurred in >5% of subjects were: feeling hot, nausea, headache, dizziness, chills, allodynia, vomiting, palpitations, tinnitus, ear discomfort, feeling abnormal, burning sensation, irritability, hot flush.
Purdue currently distributes, at no profit, nalmefene hydrochloride injection in single-dose vials containing 2 mg/2 mL (1 mg/mL). The vials are for use by healthcare professionals in hospital emergency departments across the country. Healthcare professionals can learn more about nalmefene hydrochloride injection at www.nalmefenehcl.com.
Zurnai is an important addition to Purdue’s Public Health Initiatives. Learn more about Zurnai at www.zurnai.com.
INDICATIONS AND USAGE
ZURNAI is indicated for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.
ZURNAI is intended for immediate administration as emergency therapy in settings where opioids may be present.
ZURNAI is not a substitute for emergency medical care.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ZURNAI is contraindicated in patients known to be hypersensitive to nalmefene hydrochloride or to any other ingredients in the product.
WARNINGS AND PRECAUTIONS
Risk of Recurrent Respiratory and Central Nervous System Depression
A recurrence of respiratory depression is possible, therefore, keep the patient under continued surveillance and administer repeat doses of ZURNAI if necessary, using a new auto-injector with each dose while awaiting emergency medical assistance.
Risk of Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists
Reversal of respiratory depression by partial agonists or mixed agonists/antagonists such as buprenorphine and pentazocine, may be incomplete. Repeat doses of ZURNAI may be required.
Precipitation of Severe Opioid Withdrawal
The use of ZURNAI in patients who are opioid dependent may precipitate opioid withdrawal.
Abrupt postoperative reversal of opioid depression may result in adverse cardiovascular (CV) effects. These events have primarily occurred in patients who had preexisting CV disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of ZURNAI.
In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may include the following signs and symptoms: convulsions, excessive crying, and hyperactive reflexes. Monitor the patient for the development of the signs and symptoms of opioid withdrawal.
Risk of Opioid Overdose from Attempts to Overcome the Blockade
Attempts to overcome opioid withdrawal symptoms caused by opioid antagonists with high or repeated doses of exogenous opioids may lead to opioid intoxication and death.
ADVERSE REACTIONS
Most common adverse reactions (>5%) are feeling hot, nausea, headache, dizziness, chills, vomiting, allodynia, palpitations, tinnitus, ear discomfort, feeling abnormal, burning sensation, hot flush, and irritability.
USE IN SPECIFIC POPULATIONS
Pregnancy
An opioid overdose is a medical emergency and can be fatal for the pregnant woman and fetus if left untreated. Treatment with ZURNAI for opioid overdose should not be withheld because of potential concerns regarding the effects of ZURNAI in the fetus.
Pediatric Use
The safety and effectiveness of ZURNAI for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, have not been established in pediatric patients younger than 12 years of age.
Geriatric Use
Clinical studies of nalmefene hydrochloride injection did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Please read Full Prescribing Information
To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1 888-726-7535, option 2, or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.
Intended for healthcare professionals of the United States of America only.
About Purdue Pharma L.P.
Purdue Pharma and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers. Purdue and its subsidiaries focus on balancing innovative science with clinically effective, compassionate care. The Company’s goal is to serve patients who rely on its medicines, pursue its pipeline of branded and generic medications, and introduce medicines that will help save and improve lives. Purdue continues to work tirelessly with creditors to reach a new settlement that delivers billions of dollars of value for opioid crisis abatement.
For more information, visit www.purduepharma.com.
References
- Zurnai™ (nalmefene injection) Auto-Injector Full Prescribing Information. Purdue Pharma L.P.; 2024.
- Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics. 2024. Available at: https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. Accessed July 30, 2024.
- Friedman J, Hadland S. The overdose crisis among U.S. adolescents. N Engl J Med. 2024;390:97-100.
- Volkow ND, Collins FS. N Engl J Med. 2017;377(4):391-394.
- Nalmefene HCl Injection Full Prescribing Information. Purdue Pharma L.P.; 2022.
- Opvee® Full Prescribing Information. Indivior Inc.; 2023.
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