Purdue Pharma Completes Phase 1 Study of Nalmefene for Opioid Overdose Reversal in Emergency Departments
Key Insights
Purdue Pharma (search) has concluded the first phase of the COINED study, which investigates nalmefene hydrochloride injection's effectiveness in emergency departments for opioid overdose (search) reversal.
The study assesses nalmefene's performance against naloxone, focusing on successful reversal rates, dosages, length of stay, and the incidence of precipitated withdrawal symptoms.
Nalmefene, a longer-acting opioid antagonist, is being examined for its impact on patient outcomes in the context of the evolving opioid crisis, with results expected later this year.
Purdue Pharma (search) has announced the completion of the first phase of the Clinical Outcomes from Injectable Nalmefene in the Emergency Department (COINED) study. This observational, retrospective cohort study examines the use of nalmefene hydrochloride (HCl) injection for the reversal of opioid overdoses in real-world emergency department (ED) settings. The results of the study are anticipated later this year.
The COINED study aims to measure the frequency of successful reversal of acute opioid toxicity following administration of nalmefene or naloxone, as well as the dosages used. Researchers are 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.
Study Design and Objectives
The COINED study is a 14-month observational retrospective cohort study involving approximately 60 patients who were administered nalmefene with or without naloxone and approximately 60 patients who were administered only naloxone in the ED. The study took place in Emergency Departments at UC San Diego Health (search) and El Centro Regional Medical Center (search). The choice of opioid antagonist administration was based on the clinical judgments of the patients’ healthcare providers.
According to Justin Seltzer, MD, Emergency Medicine Physician and Medical Toxicologist at UC San Diego Health (search), "The study was designed to better understand how long-acting reversal agents impact patients in today’s rapidly evolving opioid environment. The results of this study could provide information that can help health care providers make informed treatment decisions for their patients."
Nalmefene Hydrochloride Injection
Nalmefene hydrochloride injection is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression (search), induced by either natural or synthetic opioids, and in the management of known or suspected overdose. It is available as a 2mg/2mL (1mg/1mL) vial. The medication is contraindicated in patients with a known hypersensitivity to the product.
Importance of the Study
The study's focus on nalmefene is particularly relevant given its longer duration of action compared to naloxone. This extended action may be beneficial in preventing recurrent respiratory depression (search), a significant concern in opioid overdose (search) cases, especially those involving long-acting opioids such as methadone.
Thomas Alfieri, PhD, Director of Medical Affairs Strategic Research at Purdue Pharma (search), stated, “Consistent with recent recommendations from the American College of Medical Toxicology and the American Academy of Clinical Toxicology, we hope this study will provide robust data on nalmefene administrations including the effectiveness of nalmefene in ED settings.”
Safety Considerations
While nalmefene 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. Common adverse reactions reported in clinical trials include nausea (18%), vomiting (9%), tachycardia (5%), and hypertension (5%).