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FDA approves Narcan for over-the-counter sale to "combat the overdose crisis"

The U.S. recorded 101,750 overdose deaths from 2021 to 2022, mostly caused by synthetic opioids such as fentanyl.


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The growing crisis of excessive drug use in the country led the Food and Drug Administration (FDA) on Wednesday to approve Narcan, an opioid overdose reversal medication, for over-the-counter sale without a prescription.

In a statement, the FDA reported that the nasal spray is the first naloxone product approved for over-the-counter use. This drug reverses the effects of an overdose and is the standard treatment against the life-threatening effects of opioids:

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.

Emergent BioSolutions, the company that produces Narcan, said the drug will be available in pharmacies, authorized stores and even online by the end of the summer.

Some doses will only be available by prescription

The drug was first approved by the FDA in 2015, but it needed to be prescribed by a specialist. As for its price, two doses usually cost around $50.

Currently, despite its over-the-counter sale, some formulations and high doses of the drug will still be sold by prescription only:

Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.

Drug crisis

The country recorded 101,750 overdose deaths from Oct. 1, 2021 to Sept. 30, 2022. Many of these were caused by synthetic opioids such as fentanyl. As previously reported by Voz Media, overdose deaths among children and adolescents soared 113% from 2020 to 2021, registering the highest rate in decades.

Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research said the approval will help "combat the overdose crisis."

Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis.