The US Food and Drug Administration has given its approval for Narcan, a 4 milligram naloxone hydrochloride nasal spray, for over-the-counter use without a prescription.
Naloxone is an opioid overdose reversal medication and is a standard treatment for opioid overdose.
Narcan’s approval paves the way for the life-saving medication to be sold directly to consumers in drug stores, convenience stores, grocery stores, and gas stations as well as online.
The drug’s manufacturer will determine the timeline for availability and price of the OTC product. Narcan nasal spray was originally approved as a prescription drug in 2015.
The manufacturer provided data showing that the drug is safe and effective for use as directed in its proposed labeling.
The application to approve Narcan nasal spray for OTC use was granted priority review status and was subject to an advisory committee meeting in February 2023, where members voted unanimously to recommend it be approved for marketing without a prescription.
The FDA has taken several measures to facilitate access to naloxone products, which rapidly reverses the effects of opioid overdose.
In November 2022, the agency announced that certain naloxone products have the potential to be safe and effective for over-the-counter use and encouraged sponsors to submit applications for approval of OTC naloxone products.
The agency previously designed, tested, and validated a model naloxone Drug Facts Label (DFL) with easy-to-understand pictograms on how to use the drug to encourage manufacturers to pursue approval of OTC naloxone products.
The FDA is committed to addressing the complexities of the overdose crisis and continues to work on initiatives such as supporting primary prevention, encouraging harm reduction, advancing evidence-based treatments for substance use disorders, and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks. – BusinessNewsAsia.com