The Road to Over-the-Counter Naloxone: FDA Releases Federal Register Notice

We may be one step closer to nonprescription naloxone.

To encourage sponsor application for over-the counter naloxone, the US Food and Drug Administration (FDA) today issued a Federal Register notice, “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use,” that could help facilitate the development and potential approval of nonprescription naloxone drugs.1

“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Robert M. Califf, MD. “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible.”

The notice states that naloxone drug products up to 4 mg nasal spray and up to 2 mg autoinjector for intramuscular or subcutaneous use may be safe and effective for nonprescription use. Although this notice does not mean nonprescription/over-the-counter naloxone is immediately available, it does make application holders aware of the willingness of the FDA to consider nonprescription naloxone drug products. First, the FDA needs additional data, including product-specific data on the user interface design, such as packaging and labeling.

This is not the first step the FDA has taken to improve access to naloxone. In September, the FDA issued guidance to clarify that certain Drug Supply Chain Security Act requirements do not apply to naloxone distribution to harm reduction programs during the Opioid Public Health Emergency.

“The agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose, and death in the US through the four priorities of the framework, including: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks,” the FDA shared in a new release.

Reference

1. FDA announces preliminary assessment that certain naloxone products have the potential to be safe and effective for over-the-counter use. US Food and Drug Administration. News release. November 15, 2022. https://www.fda.gov/news-events/press-announcements/fda-announces-preliminary-assessment-certain-naloxone-products-have-potential-be-safe-and-effective?utm_medium=email&utm_source=govdelivery