The FDA has approved Emergent Biosolutions’ sNDA for OTC sales of Narcan naloxone nasal spray, 4 mg, for reversal of opioid overdose. Narcan was first approved for prescription use in the US in 2015. The agency accepted the sNDA for review in December 2022, and the Nonprescription Drugs and Anesthetic and Analgesic Drug Products advisory committees voted unanimously in favor of approval in February 2023. Emergent says that it expects the nasal spray to be available over the counter in the US “by late summer.”
The FDA notes that 4 mg generic naloxone nasal sprays will also now be required to go through the application process for an OTC switch. The agency recently accepted an ANDA from Amneal for a generic version of Narcan. Teva launched a generic of Narcan in December 2021 and Padagis launched its generic in June 2022. The agency added that, “The approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but determinations will be made on a case-by-case basis and the FDA may contact other firms as needed.”
Emergent Biosolutions President and CEO Robert G. Kramer commented, “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. 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.”
FDA Commissioner Robert M. Califf said, “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,. 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.”
FDA Center for Drug Evaluation and Research Director Patrizia Cavazzoni added, “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. 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. 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.”
Read the Emergent Biosolutions press release.
Read the FDA press release.
