The FDA announced today that it approved Narcan 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter, nonprescription use.
Narcan rapidly reverses the effects of opioid overdose and remains the standard treatment for such an overdose. Approval allows direct-to-consumer sales in places like drug stores, convenience stores and more. The FDA nod comes about six weeks after an agency committee voted unanimously in favor of OTC use.
This marks the first approval for a naloxone product for use without a prescription. Emergent BioSolutions received the approval for Narcan.
In a news release, the FDA said Emergent BioSolutions determines the timeline for the OTC product’s availability and price. The agency intends to work with all stakeholders to facilitate the continued availability of Narcan nasal spray products during the time needed to implement the OTC status — which could take months.
Other formulations and dosages of Narcan remain available by prescription only.
Narcan first received FDA approval in 2015 as a prescription drug. OTC approval requires a change in labeling, FDA said. Approval may also affect the status of other brand-name naloxone nasal spray products at the same dosage or less. However, the FDA intends to make determinations on a case-by-case basis.
“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,” said FDA Commissioner Dr. Robert Califf. “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.”