US approves over-the-counter Narcan sales amid overdose epidemic

Decision will ‘help reduce opioid overdose deaths throughout the country,’ says head of drug agency

WASHINGTON – The US Food and Drug Administration (FDA) approved Wednesday the sale of over-the-counter Narcan, a powerful drug used to reverse opioid overdoses.

Narcan, the best-known form of naxalone, is a nasal spray that works to quickly counteract opioid overdoses. The FDA’s action comes as the US continues to battle a dire overdose epidemic that has gained momentum with the use of fentanyl, a powerful synthetic opioid that is many times stronger than heroin.

More than 101,750 overdose-related deaths were recorded from October 2021 through October 2022, with the vast majority related to synthetic opioids like fentanyl, according to US data.

“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,” said FDA Commissioner Robert Califf, using an acronym to refer to over-the-counter.

“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,” he added.

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