The Food and Drug Administration (FDA) has approved Narcan, a naloxone product that is the standard treatment for opioid overdose, for over-the-counter, non-prescription use.
It is the first time the FDA has approved an OTC naloxone product, and the move was met with support from healthcare groups and health leaders as the nation continues to face an ongoing opioid abuse and overdose crisis. According to the FDA, there were more than 101,750 reported fatal overdoses in the 12-month period ending October 2022. The overdose crisis is primarily being driven by fentanyl, which is a synthetic opioid. Fentanyl overdoses can be treated with Narcan, but its accessibility is crucial.
The specific product approved was Narcan, 4 milligram naloxone hydrochloride nasal spray. The medication can reverse an opioid overdose and is a critical, life-saving product now able to be sold directly to consumers in places like pharmacies, convenience stores, grocers, gas stations and online, the FDA said.
Availability and price of the OTC Narcan will be determined by the manufacturer, and the FDA stated it will work with all stakeholders as the product transitions from prescription to OTC availability, which could take months.
“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 M. Califf, MD, said in a statement. “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 American Medical Association voiced its support for the decision, which the association said it has long championed.
“While government decisions are often incremental, FDA’s decision will transform how we compassionately and logically respond to the overdose epidemic,” Bobby Mukkamala, MD, chair of the AMA Substance Use and Pain Care Task Force, said in a statement March 29. “More lives will be saved within days of naloxone being easily available at grocery stores and pharmacies. If it weren’t for naloxone, there would be tens of thousands more Americans dying from opioid overdose, including those related to illicitly manufactured fentanyl.”
The AMA also recommended that all manufacturers of naloxone submit OTC applications with the FDA, as only one manufacturer is approved for OTC use.
“There is no reason for other manufacturers to delay,” AMA said.
Additionally, the association, which represents 271,660 members, urged manufacturers and retailers to work together to make the OTC product prominent on store shelves. The AMA also urged that all payers must continue to, or start to cover, naloxone at no- or low-cost, and naloxone should be treated like other preventive health medications covered by insurance, such as aspirin, vitamin D and fluoride.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."