Opioid overdose drug Narcan approved for over-the-counter use by FDA

The Food and Drug Administration on Wednesday approved sales of the lifesaving opioid overdose medication Narcan without a prescription.

The agency said the nasal spray is the first naloxone product approved for use without a prescription.

Naloxone is a medication that rapidly reverses the effects of an opioid overdose and is the standard treatment for opioid overdose. 

The U.S. reported more than 101,750 fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl. 

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“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country,” FDA Commissioner Dr. Robert Califf said in a statement. “We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”   

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Emergent BioSolutions, the company that produces Narcan, said it will make the drug available on U.S. store shelves and at online retailers by late summer.

Some formulations and dosages of naloxone will remain available by prescription only.

While pharmacies could sell naloxone without a prescription because officials in every state have allowed it, not every pharmacy carries it and buyers have to pay for the medication. While the price varies, two doses often cost around $50.

Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. In February of this year, advisory committee members voted unanimously to recommend it be approved for marketing without a prescription. 

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The agency noted that this approval may also impact the status of other brand-name naloxone nasal spray products of 4 milligrams or less, but that determinations will be made on a “case-by-case basis.” 

Narcan is the best-known form of naloxone. Police and other first responders also often carry it.

Reuters and The Associated Press contributed to this report.