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.

Recent Activities

• FDA Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose
• FDA approves higher-dose naloxone nasal spray product
• FDA announces shelf-life extension for naloxone nasal spray
• FDA Approves Second Over-the-Counter Naloxone Nasal Spray Product

Stakeholder Meetings

• FDA Stakeholder Call: Expanding Access to Naloxone
  • March 2023: Stakeholder call to discuss next steps for nonprescription naloxone following the first nonprescription naloxone approval.
• FDA Stakeholder Call: Harm Reduction and Naloxone Access
  • November 2022: Stakeholder call to discuss naloxone access and emphasize support for harm reduction programs’ ability to acquire FDA-approved naloxone products.
• Naloxone Access: Answering Questions
  • March 2022: Public workshop facilitated by the Reagan-Udall Foundation to explore some of the most frequently asked questions about access to naloxone.

Public Workshops

• Understanding Fatal Overdoses to Inform Product Development and Public Health Interventions to Manage Overdose
  • March 2023: Public workshop facilitated by the Reagan-Udall Foundation to understand fatal overdoses, with the goal of informing product development and public health interventions to manage overdoses.

Resources

• Food and Drug Administration Overdose Prevention Framework | FDA
• Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention
• Having Naloxone on Hand Can Save a Life During an Opioid Overdose
• Opioid Medications