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FDA Approves Narcan for Over-The-Counter Use
The US Food and Drug Administration (FDA) on Wednesday announced that it has approved Narcan, 4 milligram naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use. Narcan becomes the first naloxone product approved for use without a prescription.
The decision will allow the opioid overdose reversal medication, which was first approved by the FDA as a prescription medication in 2015, to be sold directly to consumers in grocery stores, pharmacies, gas stations, and other locations, as well as through online vendors. Other naloxone formulations and dosages will continue to be available by prescription only.
A timeline for product availability and price of the OTC formulation will be determined by its manufacturer, Emergent Biosolutions. The FDA said in a news release that it will work with stakeholders to help facilitate continued availability of naloxone nasal spray products during the transitional period for switching Narcan from prescription to OTC status, a process that could take several months.
“The [FDA] has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” FDA Commissioner Robert M. Califf, MD, said in the release. “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.”
The FDA’s decision to make Narcan an OTC product is win for organizations that have advocated for the change, including the National Council for Mental Wellbeing. Earlier this month, the National Council issued a statement from its president and CEO, Chuck Ingoglia, lauding the FDA for “follow the advice of its Nonprescription Drugs Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee,” which unanimously voted in a joint meeting in February to recommend that Narcan become the first opioid overdose reversal medication to receive OTC status.
“No single approach will end overdose deaths, but making Narcan easy to obtain and widely available likely will save countless lives annually. Making Narcan easy to obtain also signals our willingness to take meaningful steps to help those with a substance use challenge,” Ingoglia said in a follow-up statement emailed to media on Wednesday. “While Narcan provides a practical solution to a pervasive problem, making it available over the counter demonstrates our humanity. Narcan represents a second chance. By giving people a second chance, we also give them an opportunity to enter treatment, if they so choose.
“Making Narcan available over the counter represents a decisive, practical and humane approach to help people and flatten the curve of overdose deaths.”
The upcoming Rx and Illicit Drug Summit, April 10-13 in Atlanta, Georgia, will include a session on the implications of nonprescription naloxone. For more information, visit rx-summit.com.
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