FDA Approves New Opioid Reversal Nasal Spray, A Harm Reduction Tool

On May 22, 2023, the FDA approved Opvee, a nalmefene hydrochloride nasal spray that can reverse an opioid overdose in patients 12 and older. This approval adds a harm-reduction tool to existing tools, including naloxone, another opioid reversal medication.

According to the FDA statement, nalmefene is an opioid receptor antagonist that blocks the opioid receptors in the brain, preventing binding. Indivior PLC, the manufacturer of this medication, notes that the drug can reverse opioid-induced respiratory depression, with patients starting to improve within five minutes of administration.

Opvee is intended for patients 12 and older experiencing opioid-related respiratory or central nervous system depression. The drug is to be used immediately as an emergency response tool but does not replace emergency medical care, meaning patients should seek professional treatment after use.

Despite its utility as a potential harm-reduction tool, Opvee has some associated risks that users and healthcare professionals must be aware of. Among those risks are the potential for recurrent respiratory or central nervous system repression, interactions with partial agonists or agonist–antagonist mixtures, withdrawal potential in opioid-dependent patients, and an elevated risk of cardiovascular effects.

Beyond those severe risks, the most common adverse reactions linked to Opvee use are nasal discomfort, headache, nausea, vomiting, anxiety, fatigue, decreased appetite, hyperhidrosis, throat irritation, and erythema.

The FDA notes roughly 103,000 fatal overdoses — most of which involved a synthetic opioid — in the United States between November 2021 and November 2022. Although naloxone and its increasing availability have proven to be a successful harm-reduction tool, healthcare professionals and public health officials continue to look for additional tools to minimize overdose deaths.

With that in mind, the FDA granted priority review to Opvee. Based on the results of a pharmacodynamic study, the organization has approved the drug as a prescription medication available to harm reduction groups and first responders.

“The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage harm reduction by supporting the development of novel overdose reversal products,” said FDA Commissioner Robert M. Califf, MD, in the FDA press release. “On the heels of the FDA’s recent approval of the first over-the-counter opioid reversal agent, the availability of nalmefene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups, and emergency responders.”