FDA Approves Opioid Overdose Treatment Narcan for Over-the-Counter Sales
An over-the-counter nasal spray version of Narcan, the medication used to reverse the effects of an opioid overdose, was officially approved by the Food and Drug Administration today, March 29.
The move means the medication, also known as naloxone, will be available in drug stores, grocery stores, gas stations, and even vending machines by late summer, according to The New York Times. The widespread availability of naloxone has been sought by public health advocates for years, with many believing it could help curb the high rate of overdose fatalities. There were over 101,750 reported fatal overdoses in a 12-month period ending Oct. 2022, with many caused by synthetic opioids like fentanyl.
FDA Commissioner Robert M. Califf said the agency had “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.” He continued: “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.”
While naloxone has been readily available at pharmacies across the U.S. via standing prescriptions, there have been many barriers to actual access. According to a recent study by the Reagan-Udall Foundation, these include everything from the physical locations of pharmacies (especially in rural areas) and prescription fill limits to cost (especially for those without health insurance) and the stigma around illicit drug use (that includes pharmacies choosing not to carry Narcan, or people being wary of asking for it).
The OTC version of naloxone will certainly address some of these problems, though one big question remains around cost. A two-dose pack of prescription Narcan is often free or available with a co-pay of under $10 for those covered by Medicaid or private insurance. But for those without insurance, the medication can sometimes cost $70 or more. Emergent BioSolutions, the pharma company that makes Narcan and received the FDA’s first approval for the OTC version, did not mention the price in the statement it shared after the FDA’s decision was announced.
“We are dedicated to improving public health and assisting those working hard to end the opioid crisis — so now with leaders across government, retail and advocacy groups, we must work together to continue increasing access and availability, as well as educate the public on the risks of opioid overdoses and the value of being prepared with Narcan Nasal Spray to help save a life,” said the company’s president and CEO, Robert Kramer.
The FDA first approved Narcan nasal spray back in 2015 (it was previously available as an intravenous shot). In 2019, the agency started working to make the medication available over the counter, designing and approving a Drug Facts Label that manufacturers could use to develop their own OTC naloxone products.
“The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status,” said Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research. “Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”
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