Purdue Launches Opioid Reversal Nalmefene

Purdue Pharma has introduced nalmefene hydrochloride injection, which 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 opioid overdose.

Craig Landau, M.D.

“We believe nalmefene will be an important treatment option to help address the growing and continuing crisis of opioid overdose deaths, including those due to fentanyl and other synthetic opioids,” Craig Landau, M.D., president and CEO, Purdue Pharma, said in a press release. “We decided to provide this medication without market exclusivity because it is in the best interest of the public that other companies also have the ability to quickly introduce similar products if approved by FDA.”

Additionally, Purdue will distribute nalmefene for no profit as part of its commitment to help abate the opioid crisis. This is part of the company’s bankruptcy filing and settlement with 20 states to address the opioid crisis that the company, in part, helped to create. Purdue developed OxyContin (oxycodone). The company’s aggressive marketing, which incorrectly indicated that the pain reliever was not addictive, is seen as a major contributor to the abuse of this and other opioids.

The company and the Sackler family, which owned Purdue Pharma, have agreed to a settlement that would create a trust of about $6 billion to pay for claims from states, hospitals, and those impacted by addition. A judge in March 2022 has approved the settlement.

As part of the reorganization plan, Purdue will cease to exist. A new company, called Knoa Pharma, will be owned by National Opioid Abatement Trust, the trust that is being established to fund any claims brought by states. The new company will provide millions of doses of a generic version of buprenorphine and naloxone sublingual tablets, a treatment for opioid dependence. The FDA approved a generic version of buprenorphine and naloxone tablets, in 2020. The company will continue to support the development of a low-cost, nonprescription naloxone intranasal spray.