FDA permits over-the-counter sale of overdose-reversal drug Narcan. Here's how it can save lives
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The U.S. Food and Drug Administration (FDA) on Wednesday approved Narcan, a prescription four-milligram naloxone hydrochloride nasal spray, for over-the-counter use, a long-awaited move that increases widespread access to the life-saving- medicine. The Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug.
The decision will hopefully lower the nation's staggeringly high drug overdose rates, with more than 101,750 reported fatal overdoses occurring in the 12 months ending in October 2022, mostly driven by synthetic opioids like illicit fentanyl.
Naxolone rapidly reverses the effects of opioid overdose and has been the standard treatment for opioid overdose. The FDA's latest decision will permit the drug to be sold directly to consumers in drug stores, convenience stores, grocery stores, and gas stations, as well as online. It is to be noted that other formulations and dosages of naloxone will only be available by prescription.
"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, M.D, said in a statement.
The announcement comes a month after the approval of the Narcan nasal spray for OTC use was granted priority review status. It was the subject of an advisory committee meeting in February 2023, where committee members voted unanimously to recommend it be approved for marketing without a prescription, the release states.
Approval of the drug to be sold OTC is a life-saving decision
The approved nasal spray from Gaithersburg, Maryland-based Emergent BioSolutions can reverse overdoses of not only opioids but also street drugs such as heroin and fentanyl and prescription versions such as oxycodone.
Before the FDA's action, naloxone was sold in pharmacies without a prescription as permitted by officials in every state, AP reported. However, several pharmacies refused to provide the medication without the doctor's oversight to avoid encouraging illicit drug use.
Not every pharmacy carries it either. Buyers are also required to pay the full retail price (two doses can go for around $50) or with an insurance co-pay. For now, Emergent has not announced its price, but the FDA commissioner has encouraged the company to make the drug available "at an affordable price."
The FDA's approval makes naloxone the first opioid overdose reversal drug to be available without a prescription across the United States.
NBC has reported that the single dose formulated as a nasal spray won't be available until the late summer.
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