U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Drug Safety and Availability
  4. Postmarket Drug Safety Information for Patients and Providers
  5. Information about Naloxone and Nalmefene
  1. Postmarket Drug Safety Information for Patients and Providers

Information about Naloxone and Nalmefene

The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage harm reduction by supporting the availability, accessibility, and development of novel overdose reversal drugs, including naloxone and nalmefene.

Overdose Reversal Drugs

To support these efforts, the FDA approved the first over-the-counter naloxone nasal spray in March 2023 to help reduce drug overdose deaths. Naloxone is a lifesaving emergency treatment that reverses opioid overdose. It is a medicine with no abuse potential, and it is not a controlled substance. It can also be administered by individuals with or without medical training to help reduce opioid overdose deaths, as shown on CDC’s website.

The FDA also approved the first nalmefene hydrochloride nasal spray in May 2023 to reverse opioid overdose. Nalmefene is an opioid receptor antagonist that is used to treat acute opioid overdose. The newly approved product is available by prescription and is intended for use in health care and community settings.

FDA understands the importance of having such overdose reversal drugs available for community use, and the agency will continue to take key steps in encouraging and supporting harm reduction.

Stakeholder Meetings

Public Workshops



Back to Top