FDA approves first over-the-counter drug to reverse opioid overdoses

WASHINGTON — With the number of opioid overdose deaths in the U.S. increasing more than 17% in just one year, the Food and Drug Administration has approved an over-the-counter drug for opioid overdose reversal. Narcan (naloxone) reverses deadly overdoses by blocking the effect that opioids have on the nervous system. However, it must be administered as soon as an overdose is suspected. Currently, police and other first responders often carry it.

Thanks to the FDA’s decision on Wednesday, Narcan will soon be available for purchase in drug stores, convenience stores, grocery stores, gas stations, and online.

“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. 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,” FDA Commissioner Robert M. Califf said in a news release.

Emergent BioSolutions, the manufacturer, says Narcan should be available without a prescription by late summer. The FDA’s approval is only for Narcan made by Emergent BioSolutions. However, the nonprofit, Harm Reduction Therapeutics, is also seeking the same FDA green light.

Opioid deaths are the leading cause of accidental death in the United States. While most of the deaths are adults, authorities are seeing an increasing number of children overdosing. Narcan can be given to people of all ages, including babies.

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