The Food and Drug Administration has approved Narcan naloxone hydrochloride nasal spray (4 mg) for over-the-counter use, enabling the opioid overdose antidote to be sold directly to consumers in drug stores, grocery stores, convenience stores and gas stations, as well as online.
With the move, the FDA paves the way for naloxone to become readily available and provides a boost to the nation’s ongoing battle against opioid overdose, which has ballooned into a major public health issue in recent years. More than 101,750 fatal overdoses were reported across the country for the 12 months ended in October 2022, mainly driven by synthetic opioids such as illicit fentanyl, the agency noted.
“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 on Wednesday. “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.”
Approval of nonprescription Narcan nasal spray was granted to Emergent BioSolutions, which in 2018 had acquired Adapt Pharma, maker of the first needle-free formulation of naloxone cleared by the FDA. Currently, naloxone is only approved for use in injectable and nasal spray forms.
All 50 states, the District of Columbia and Puerto Rico have access laws for naloxone—including for Narcan nasal spray—that allow it to be purchased directly from pharmacists without a doctor’s prescription. Retail pharmacies rapidly made naloxone available on a nonprescription basis through the pharmacy counter as waves of opioid overdoses struck in 2010 and then in 2013, the latter reflecting a surge of overdoses from illegally made fentanyl.
Naloxone can quickly reverse opioid overdose and, therefore, be life-saving for anyone regularly taking opioids or who knows someone taking these drugs. Another possible reason to have naloxone on hand is that anyone with opioids or opioid pain relievers in their home may run the risk that children or guests unintentionally ingest the medication.
“CHPA applauds FDA for taking a critical step forward today in public health by making Narcan available over-the-counter—previously only available with a prescription—which will remove many of the barriers and stigmas attached to this life-saving emergency therapy for opioid overdoses,” according to Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville.
“Since naloxone is used in emergency situations where every second counts, OTC access will now give individuals, families, friends and other responders quicker access to this medication. It will also increase the likelihood that individuals will obtain and carry Narcan, which will potentially save more lives,” Melville explained. “Today’s decision will positively impact millions of Americans and provide benefits that Rx-to-OTC-switch products have always delivered: increased access to safe, effective and affordable medicines for better health care.”
Emergent will determine the availability timeline and price of its OTC Narcan nasal spray, the FDA said, adding that the agency will work with all stakeholders to help facilitate the switch of Narcan nasal spray products from prescription to OTC status, “which may take months.” FDA-approved generic naloxone nasal spray (4 mg) products that rely on Narcan as their reference listed drug product will require a labeling change. Other formulations and dosages of naloxone will remain available by prescription only.
“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,” stated Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “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.”
In recent years, the FDA has worked toward OTC status for Narcan nasal spray, approved for prescription use in 2015, as part of efforts to broaden access to naloxone products. The agency said in 2019 it had created a model naloxone Drug Facts Label with pictograms on how to use the drug to encourage manufacturers to pursue approval of OTC naloxone products. Then last November, the FDA announced that certain naloxone products, including nasal spray, have the potential to be safe and effective for OTC use and manufacturers should submit drug applications. That was followed this past February by an advisory committee meeting in which members voted unanimously to recommend OTC Narcan nasal spray be approved for marketing without a prescription.
“We can prevent overdoses and save lives by making naloxone more accessible, and at the same time, we can ensure equitable access to essential health care,” HHS Secretary Xavier Becerra said in a statement on Wednesday. “Today’s FDA action to allow access to naloxone without a prescription is another strong step forward in advancing HHS’ Overdose Prevention Strategy.”