STAMFORD, Conn.--(BUSINESS WIRE)--Purdue Pharma has completed the first phase of a study examining the use of nalmefene hydrochloride (HCI) injection in real-world emergency department (ED) settings. Researchers are now conducting data analysis, with study results expected later this year. The research was funded by Purdue.
Nalmefene hydrochloride injection is available as a 2mg/2mL (1mg/1mL) vial, and is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids and in the management of known or suspected overdose. Nalmefene hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product. 1
“We distribute nalmefene injection for no profit, as part of our commitment to providing opioid overdose treatments that can help save lives in communities across the country,” said Craig Landau, MD, President and CEO, Purdue. “We look forward to learning about the results of the study.”
The Clinical Outcomes from Injectable Nalmefene in the Emergency Department (COINED) study is designed to measure the frequency of successful reversal of acute opioid toxicity following administration of nalmefene or naloxone, as well as the dosages used. The study is also evaluating the clinical course of patients after receiving an opioid antagonist, including length of stay in the ED, frequency of precipitated withdrawal, and any additional medications used to treat patient symptoms.
“The study was designed to better understand how long-acting reversal agents impact patients in today’s rapidly evolving opioid environment,” said Justin Seltzer, MD, Emergency Medicine Physician and Medical Toxicologist at UC San Diego Health. “The results of this study could provide information that can help health care providers make informed treatment decisions for their patients.”
The COINED study is a 14-month observational retrospective cohort study with secondary data analysis from electronic health records and medical charts of approximately 60 patients who were administered nalmefene with or without naloxone in the ED and approximately 60 patients who were administered only naloxone in the ED. The study took place in Emergency Departments at UC San Diego Health and El Centro Regional Medical Center. Choice of opioid antagonist administration was made according to the clinical judgements of patients’ health care providers.
“Consistent with recent recommendations from the American College of Medical Toxicology and the American Academy of Clinical Toxicology 2, we hope this study will provide robust data on nalmefene administrations including the effectiveness of nalmefene in ED settings,” said Thomas Alfieri, PhD, Director of Medical Affairs Strategic Research at Purdue Pharma.
Health care professionals can learn more about nalmefene at www.nalmefenehcl.com.
IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.
CONTRAINDICATION
Nalmefene Hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product.
WARNINGS AND PRECAUTIONS
Use of Nalmefene Hydrochloride injection in Emergencies
Nalmefene Hydrochloride injection, like all drugs in this class, is not the primary treatment for ventilatory failure. In most emergency settings, treatment with Nalmefene Hydrochloride injection should follow, not precede, the establishment of a patent airway, ventilatory assistance, administration of oxygen, and establishment of circulatory access.
Risk of Recurrent Respiratory Depression
Accidental overdose with long acting opioids [such as methadone and levo-alpha-acetylmethadol (LAAM)] may result in prolonged respiratory depression. Respiratory depression in both the postoperative and overdose setting may be complex and involve the effects of anesthetic agents, neuromuscular blockers, and other drugs. While Nalmefene Hydrochloride injection has a longer duration of action than naloxone in fully reversing doses, the physician should be aware that a recurrence of respiratory depression is possible, even after an apparently adequate initial response to Nalmefene Hydrochloride injection treatment.
Patients treated with Nalmefene Hydrochloride injection should be observed until, in the opinion of the physician, there is no reasonable risk of recurrent respiratory depression.
Cardiovascular Risks with Narcotic Antagonists
Pulmonary edema, cardiovascular instability, hypotension, hypertension, ventricular tachycardia, and ventricular fibrillation have been reported in connection with opioid reversal in both postoperative and emergency department settings. In many cases, these effects appear to be the result of abrupt reversal of opioid effects.
Although Nalmefene Hydrochloride injection has been used safely in patients with pre-existing cardiac disease, all drugs of this class should be used with caution in patients at high cardiovascular risk or who have received potentially cardiotoxic drugs.
Risk of Precipitated Withdrawal
Nalmefene Hydrochloride injection, like other opioid antagonists, is known to produce acute withdrawal symptoms and, therefore, should be used with extreme caution in patients with known physical dependence on opioids or following surgery involving high doses of opioids. Imprudent use or excessive doses of opioid antagonists in the postoperative setting has been associated with hypertension, tachycardia, and excessive mortality in patients at high risk for cardiovascular complications.
Incomplete Reversal of Buprenorphine
Preclinical studies have shown that nalmefene at doses up to 10 mg/kg (437 times the maximum recommended human dose) produced incomplete reversal of buprenorphine-induced analgesia in animal models. This appears to be a consequence of a high affinity and slow displacement of buprenorphine from the opioid receptors. Hence, Nalmefene Hydrochloride injection may not completely reverse buprenorphine-induced respiratory depression.
Use in Pediatric Patients
Safety and effectiveness of nalmefene hydrochloride injection in pediatric patients have not been established.
ADVERSE REACTIONS
The most common adverse reactions (>1%) reported in clinical trials with nalmefene injection were nausea (18%), vomiting (9%), tachycardia (5%), hypertension (5%), postoperative pain (4%), fever (3%), and dizziness (3%).
To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please read Prescribing Information available here.
For more information, visit www.nalmefenehcl.com.
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
- Nalmefene Hydrochloride Injection 2mg/2mL (1mg/1mL) [Full Prescribing Information]. Stamford, CT: Purdue Pharma L.P., 02/08/2022. https://www.accessdata.fda.gov/spl/data/d4bb0797-a4ed-4ed4-9904-604433eea4ff/d4bb0797-a4ed-4ed4-9904-604433eea4ff.xml. Accessed August 5, 2024.
- Stolbach AI, Mazer-Amirshahi M, Nelson LS, et al.; American College of Medical Toxicology and the American Academy of Clinical Toxicology Position Statement: Nalmefene should not replace naloxone as the primary opioid antidote at this time. J Med Toxicol. 2024; 20:64–67. https://doi.org/10.1007/s13181-023-00981-z
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