FDA Approves Purdue Pharma’s Nalmefene Hydrochloride Injection to Treat Opioid Overdoses

The agency has given the greenlight to the abbreviated new drug application for the overdose-reversal medication.

The FDA has approved an abbreviated new drug application for nalmefene hydrochloride injection from Purdue Pharma in the 2 mg/2 mL strength, according to a company statement.1

Nalmefene is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, which includes respiratory depression, induced either by natural or synthetic opioids. Additionally, it is indicated for the management of known or suspected opioid overdoses.1

“Nalmefene is an important part of our commitment to help abate the opioid crisis,” Craig Landau, MD, CEO and president of Purdue Pharma, said in a statement.1

“This FDA approval is an example of our ongoing efforts to help provide much-needed treatment for patients and health care providers,” he said.1 “Nalmefene will be an important treatment option to address the opioid crisis, which has accelerated during the COVID-19 pandemic and is being fueled by the increasing prevalence of illicitly manufactured synthetic opioids.”

The injection is in a vial formulation that is intended to be used by health care professionals in emergency departments. It is suggested that individuals treated with nalmefene hydrochloride should be observed until there is no risk of recurrent respiratory depression.1

The company expects to distribute injectable nalmefene by mid-2022 and will be distributing the injection for no profit.1

It is contraindicated for individuals with a known hypersensitivity to the product.1

An accidental overdose with long-acting opioids could result in prolonged respiratory depression, and while nalmefene hydrochloride has a longer duration than naloxone, the recurrence of respiratory depression is possible.1

Additionally, there are cardiovascular risks with narcotic antagonists, risk of precipitated withdrawal, and incomplete reversal of buprenorphine.1

The most common adverse events reported were dizziness, fever, hypertension, nausea, postoperative pain, tachycardia, and vomiting.1

Nearly 841,000 individuals have died from a drug overdose since 1999, and in 2019, 70,630 deaths occurred in the United States, according to the CDC.2

Opioids are the main driver of drug overdoses deaths, with synthetic opioids accounting for 72.9% of deaths, according to the CDC.2

Approximately 67.9% of the increase in death rates involving synthetic opioids occurred in the West from 2018 to 2019, and the largest increase in death rates involving psychostimulants occurred in the Northeast at approximately 43.8%.2

This shows a clear switch, as the West previously had the highest rates involving psychostimulants, and the Northeast had the highest rates involving of synthetic opioids.2

There was no state, from 2018 to 2019, where a significant decrease was evident, according to the CDC.2

Reference

1. FDA approves Nalmefene HCl injection, 2mg/2mL (1mg/1mL) for the treatment of known or suspected opioid overdose with natural or synthetic opioids. Business Wire. News release. February 23, 2022. Accessed February 25, 2022. https://www.businesswire.com/news/home/20220223005962/en

2. Drug overdose deaths. CDC. Updated March 3, 2021. Accessed February 25, 2022. https://www.cdc.gov/drugoverdose/deaths/index.html