FDA approves Narcan, a nasal spray that reverses opioid overdose

FDA approves Narcan, a nasal spray that reverses opioid overdose | The Lifesciences Magazine

The U.S. Food and Drug Administration (FDA) has approved the sale of Narcan, the most widely recognized version of naloxone, without a prescription. This move paves the way for Narcan to become the first opioid treatment drug to be sold over the counter, which advocates believe is a crucial step in controlling the nationwide overdose crisis. Narcan, a nasal spray manufactured by Emergent BioSolutions, can reverse opioid overdoses, including street drugs such as heroin and fentanyl, as well as prescription versions such as oxycodone.

A Lifesaver

The majority of the 100,000 annual overdose deaths in the U.S. are related to opioids, primarily synthetic versions such as fentanyl that can take multiple doses of naloxone to reverse. Advocates believe that making naloxone available to those who are most likely to be around overdoses, including people who use drugs and their relatives, is a crucial strategy to address the overdose crisis. Chuck Ingoglia of the National Council for Mental Wellbeing stated that this decision is a “decisive, practical, and humane approach to help people and flatten the curve of overdose deaths.”

New York City health commissioner on FDA approval of over-the-counter Narcan

Making Narcan More Accessible

While pharmacies in every state have been allowed to sell naloxone without a prescription, not every pharmacy carries it, and buyers have to pay for the medication with either an insurance co-pay or the full retail price. Narcan typically costs around $50 for two doses. Making naloxone available over the counter clears the way for Narcan to be made available in places without pharmacies, such as convenience stores, supermarkets, and online retailers. This could help many people who don’t seek services or who live in places where they’re not available.

However, it remains to be seen how many stores will carry it and what the prices will be. The U.S. Centers for Medicare and Medicaid Services says that coverage of over-the-counter naloxone would depend on the insurance program, and they have not given any official guidance.

While some people are concerned about getting naloxone at pharmacies because their insurers will know they’re getting it, making it available over the counter would allow people to pick it up without stigma attached to it. Emergent had to conduct a study examining whether untrained people could follow directions for using Narcan. Last month, an FDA expert panel voted to make the drug available over the counter, despite numerous errors in using the device reported in the company study.

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