FDA approves over-the-counter sales of Narcan opioid overdose treatment
Jack Birle
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The Food and Drug Administration announced Wednesday that it has approved over-the-counter sales of a nasal treatment for opioid overdoses for the first time.
Narcan has been given the seal of approval by the FDA to hit pharmacy shelves, with the agency saying Wednesday’s action paves the way for the “life-saving medication” to be made easily available to those who need it.
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“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency 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 Califf said in a statement.
“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,” he added.
The drug was initially approved in 2015 for prescription use but has now been approved for over-the-counter sale. An FDA advisory panel unanimously voted to recommend the nasal treatment for OTC sales last month.
The FDA says the timeline for availability and the price of the OTC treatment will be determined by the manufacturer of Narcan, Emergent BioSolutions.
Robert G. Kramer, president and CEO of Emergent BioSolutions, lauded the FDA’s approval of the treatment for use without a prescription, calling it a “historic milestone.”
“Today’s landmark FDA OTC approval for Narcan Nasal Spray marks a historic milestone as we have delivered on our commitment to make this important emergency treatment widely accessible, given the alarming rates of opioid overdoses occurring across the country,” Kramer said.
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“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,” he added.
The Centers for Disease Control and Prevention reported 101,751 opioid overdose deaths in the U.S. from October 2021 through October 2022.