Naloxone Over the Counter?

FDA weighs in on possible nonprescription naloxone drug products

(RxWiki News) Health officials are making moves that could make an overdose-preventing drug more easily accessible.

That's the latest from a federal register notice published by the US Food and Drug Administration (FDA). In the notice, the FDA included an early assessment that certain naloxone products may be "safe and effective for nonprescription use."

Naloxone is a drug that, when administered quickly at the first signs of a possible opioid overdose, can prevent potentially fatal overdoses. Currently, products that contain naloxone are prescription-only.

That limits the availability of the drug, and the FDA was showing signs that it wanted to do something about that — starting with this most recent federal register notice.

“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Dr. Robert M. Califf in a press release. “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.”

Specifically, the FDA said the following products may be safe and effective without a prescription:

  • 4 milligrams (mg) nasal spray
  • Up to 2 mg autoinjector for intramuscular (IM) or subcutaneous (SC) use

This indication is meant to let producers of naloxone products know that it might be open to applications for nonprescription naloxone products. Still, the FDA would need to follow the usual approval process, which involves reviewing in-depth data on safety and effectiveness.

In other words, there's still a long way to go, but the FDA signaled that nonprescription naloxone could be available in the future.

If you have questions about naloxone, opioids or related issues, reach out to your healthcare provider.

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Review Date: 
December 5, 2022