The U.S. Food and Drug Administration (FDA) approved the nasal spray Narcan for over-the-counter (OTC) nonprescription use, according to a press release.
The decision makes Narcan the first naloxone product to be approved for use without a prescription, and it will improve access to the medication by allowing it to be sold directly to consumers in locales such as drug stores, convenience stores, grocery stores, gas stations and online stores.
“The FDA remains committed to addressing the evolving complexities of the overdose crisis," said FDA Commissioner Robert M. Califf, M.D. "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.”
The FDA defines Narcan as a 4-milligram naloxone hydrochloride nasal spray that rapidly reverses the effects of opioid overdose and is considered the standard treatment for such a health event. Availability and product pricing will be determined by the manufacturer, and switching Narcan from prescription-only to OTC may take months. Additionally, other naloxone formulations and dosages of naloxone will remain 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,” said Patrizia Cavazzoni, M.D., 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."
