The Food and Drug Administration (FDA) has granted Fast Track designation to nalmefene HCl injection (Purdue Pharma) for the emergency treatment of known or suspected opioid overdoses.

The investigational opioid antagonist is being developed as an alternative to naloxone to reverse the effects of opioids, including respiratory depression, sedation, and hypotension. Pharmacodynamic studies have shown that nalmefene has a longer duration of action than naloxone.

Nalmefene HCl injection was previously marketed under the brand name Revex (Baxter) but was discontinued in 2008. In a press release, Purdue stated that if approved, the Company will not profit from any future sales of the drug. An open letter on the Purdue Pharma website notes several measures which the Company plans to take in order to address the opioid crisis, including ending the promotion of opioid drugs to prescribers through sales representatives.  

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“We urgently need new and potentially more effective treatments to combat opioid overdose than are available today,” said Craig Landau, MD, president and CEO, Purdue Pharma. “We will continue our efforts to make nalmefene HCl injection available as quickly as possible, as it has the potential to be an important option to help address this public health emergency.”

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