CHICAGO, IL – The Food and Drug Administration (FDA) has approved Narcan, a 4mg naloxone hydrochloride nasal spray, for over-the-counter use, making it the first naloxone product approved without a prescription.
Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. The availability of an over-the-counter version of this medication could dramatically increase access to the life-saving medication, particularly in places such as drug stores, convenience stores, grocery stores, and gas stations.
No timeline has been released for when an over the counter drug will become available, but is expected to take months to switch from prescription status.
Drug overdose remains a major public health issue 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 such as illicit fentanyl.
FDA Commissioner Robert M. Califf, M.D., stated, “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.”
Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. In accordance with the process to change a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling. The application was granted priority review status, and the advisory committee voted unanimously to recommend it be approved for marketing without a prescription.
The use of Narcan nasal spray in individuals who are opioid dependent may result in severe opioid withdrawal. The FDA has taken several measures to help facilitate access to naloxone products. In November 2022, the agency encouraged sponsors to submit applications for over-the-counter use.