FDA Approves First OTC Naloxone Nasal Spray

The U.S. Food and Drug Administration has approved Narcan, a 4mg naloxone hydrochloride nasal spray, for over-the-counter (OTC) use without a prescription. This makes it the first naloxone product to receive approval for non-prescription use. Narcan is a medication used to rapidly reverse the effects of opioid overdose and is the standard treatment for opioid overdose. This decision now allows for the life-saving medication to be sold directly to consumers in various locations such as drug stores, convenience stores, grocery stores, and gas stations, as well as online.

The availability and price of the OTC product will be determined by the manufacturer. The FDA will work with all stakeholders to ensure the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take several months. Other formulations and dosages of naloxone will remain available by prescription only.

Drug overdose remains a significant public health concern in the United States, with over 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl. The FDA’s decision to approve OTC Narcan nasal spray will help improve access to naloxone, increase the number of locations where it is available, and help reduce opioid overdose deaths throughout the country.

Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. In accordance with the process to change the status of a drug from prescription to non-prescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling. The manufacturer also showed that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional. The application to approve Narcan nasal spray for OTC use was granted priority review status and was the subject of an advisory committee meeting in February 2023, where committee members voted unanimously to recommend it be approved for marketing without a prescription.

The FDA has taken a series of measures to help facilitate access to naloxone products, including encouraging sponsors to submit applications for approval of OTC naloxone products. The agency has also designed, tested, and validated a model naloxone Drug Facts Label (DFL) with easy-to-understand pictograms on how to use the drug to encourage manufacturers to pursue approval of OTC naloxone products. The model DFL was used to support the approved application along with the results of a simulated use Human Factors validation study designed to assess whether all the components of the product with which a user would interact could be used safely and effectively as intended.

The FDA Overdose Prevention Framework remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose, and death in the U.S. The framework’s priorities include supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

The FDA has granted the OTC approval of Narcan to Emergent BioSolutions. The approval of OTC Narcan nasal spray will require a change in the labeling for the currently approved 4mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product. Manufacturers of these products will be required to submit a supplement to their applications to effectively switch their products to OTC status. The approval may also affect the status of other brand-name naloxone nasal spray products of 4mg or less, but determinations will be made on a case-by-case basis, and the FDA may contact other firms as needed.

Additionally, the FDA has designed, tested, and validated a model naloxone Drug Facts Label (DFL) with easy-to-understand pictograms on how to use the drug. This was done to encourage manufacturers to pursue approval of OTC naloxone products and ensure that consumers can use the drug safely and effectively without the supervision of a healthcare professional.

While the availability and price of the OTC Narcan nasal spray will be determined by the manufacturer, the FDA is committed to working with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the transition from prescription to OTC status. This transition may take several months, but it is crucial to ensure that there are no disruptions in access to this life-saving medication.

The approval of OTC Narcan nasal spray is a critical step in addressing the opioid overdose crisis in the United States. It will increase access to naloxone and help reduce opioid overdose deaths throughout the country. The FDA encourages the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.

In conclusion, the FDA’s approval of Narcan nasal spray for over-the-counter use is a significant milestone in the fight against the opioid overdose crisis. With the potential for consumers to purchase this medication at drug stores, convenience stores, grocery stores, and gas stations, as well as online, more lives can be saved. However, it is essential to remember that this is just one tool in a comprehensive approach to address substance use disorders and overdose prevention. The FDA remains committed to its Overdose Prevention Framework, which includes primary prevention, harm reduction, evidence-based treatments, and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray