FDA approves prescription nasal spray for opioid overdose

Key takeaways:

• The FDA said Opvee, a nalmefene hydrochloride nasal spray, represents an additional tool for treating opioid overdose.
• The nasal spray is intended for use in communities and health care settings.

The FDA has approved Opvee as the first nalmefene hydrochloride prescription nasal spray to reverse opioid overdose in adults and children aged 12 years and older, according to a press release from the agency.

Drug overdose deaths in the United States, which are largely driven by synthetic opioids like fentanyl, have long been a significant public health issue. According to data from the CDC, 2020 previously held the record for overdose deaths in a 12-month period, but there was a 14.9% increase in 2021 to 107,622. During the 12-month period ending in November 2022, there were more than 103,000 fatal overdoses in the U.S.

In late March, the FDA approved over-the-counter Narcan nasal spray for opioid overdoses. The approval of Opvee marks the first FDA approval of nalmefene hydrochloride nasal spray for use in communities and health care settings.

As an opioid receptor antagonist, nalmefene can reverse the effects of opioid overdose if administered quickly, according to the FDA. Opvee’s approval was supported by a study in people who use opioids recreationally to assess how quickly the drug works, as well as pharmacokinetic and safety studies.

“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,” FDA Commissioner Robert M. Califf, MD, said in the 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.”

The most common adverse reactions, according to the release, include dizziness, headache, nausea, nasal discomfort, vomiting, anxiety, throat irritation, fatigue, nasal congestion, skin redness, excessive sweating and decreased appetite. Additionally, using nalmefene hydrochloride in patients who are opioid-dependent could lead to opioid withdrawal.