FDA Approves First Over-the-Counter Naloxone Nasal Spray

On March 29, 2023, FDA announced its approval of Narcan (four milligram naloxone hydrochloride nasal spray) for over-the-counter (OTC), nonprescription use. Naloxone, a standard treatment for reversing the effects of opioid overdoses, has been available via prescription (Rx) since 2015. The approval was granted to Emergent BioSolutions, a biotechnology company specializing in opioid treatment products, as well as vaccines and antibody therapeutics for infectious diseases.

According to an agency press release, more than 100,000 individuals suffered fatal overdoses from October 2021 to October 2022. Primarily driven by synthetic opioids, such as illicit fentanyl, the expanded approval from FDA is designed to fulfill a “dire public health need.”

“[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,” said Robert M. Califf, commissioner, FDA, 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.”

“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Patrizia Cavazzoni, director, Center for Drug Evaluation and Research, FDA, in the release. “[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. 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.”

According to an Emergent BioSolutions company press release, the product is scheduled to be available OTC in the United States late summer 2023. This timeline was chosen to account for manufacturing changes needed for the transition from Rx packaging to OTC.

“Today’s landmark FDA OTC approval for N[arcan] 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,” said Robert G. Kramer, president and CEO, Emergent BioSolutions, in the company press release. “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 N[arcan] Nasal Spray to help save a life.”

Source: FDA, Emergent Biosolutions