WASHINGTON, D.C. — The US Food and Drug Administration (FDA) has given the green light to Narcan, a naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use. Narcan is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. This is the first naloxone product to be approved for use without a prescription, paving the way for the life-saving medication to be sold directly to consumers in drug stores, convenience stores, grocery stores, gas stations, and online.
According to statistics, drug overdose remains a major public health issue in the United States. Over 101,750 fatal overdoses were reported in the 12-month period ending in October 2022, driven primarily by synthetic opioids such as illicit fentanyl. Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug and has already been credited with saving numerous lives.
The FDA has encouraged the manufacturer to make the product accessible and affordable to the public. With the approval of OTC Narcan, the medication will be sold directly to consumers in drug stores, convenience stores, grocery stores, gas stations, and online without the need for a prescription. The FDA has taken a series of measures to help facilitate access to naloxone products, including the design, testing, and validation of a model naloxone Drug Facts Label (DFL) with easy-to-understand pictograms on how to use the drug.
The use of Narcan nasal spray in individuals who are opioid dependent may result in severe opioid withdrawal. However, the FDA remains committed to addressing the evolving complexities of the overdose crisis and is working with 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.
The approval of OTC Narcan nasal spray is expected to increase access to naloxone and help reduce opioid overdose deaths throughout the country. With the medication now available to the public without the need for a prescription, Narcan has the potential to save countless lives by quickly reversing the effects of opioid overdose.
