FDA Approves Purdue’s Opioid Overdose Reversal Nalmefene

The FDA has approved Purdue Pharma’s abbreviated new drug application for nalmefene hydrochloride injection, 2mg/2mL. Nalmefene is an opioid antagonist for the complete or partial reversal of opioid drug effects, including respiratory depression. It is expected to be available by mid-2022.

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

The company will be distributing nalmefene for no profit. 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 this week 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.

The Sackler families will have no involvement in the new company, and they are paying $4.36 billion, in addition to $225 million already paid to the United States Department of Justice.