FDA Approves Narcan Nasal Spray for Over-the-Counter Use
The live-saving medication can rapidly reverse the effects of an opioid overdose.
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The FDA aims to increase access to naloxone.
The US Food and Drug Administration said on Wednesday it has approved 4mg doses of Narcan naloxone nasal spray for over-the-counter use, with no prescription needed. Naloxone is a life-saving medication that rapidly reverses the effects of opioid overdose. The Narcan approval paves the way for naloxone nasal spray to be available to more people in places like grocery stores and gas stations as well as online, the FDA said.
First approved for prescription use in 2015, Narcan nasal spray will become the first naloxone drug to be available as an OTC product. It's an alternative to the injectable version of the medication that's been used by emergency responders for more than four decades. Amid the ongoing opioid crisis in the US, administering naloxone can help reduce opioid-related deaths. Naloxone has been used to reverse opioid overdoses in individuals of varying backgrounds, including pregnant women and the elderly.
Naloxone is available in most states without a prescription via pharmacies or local community health agencies. While some states such as Ohio, Delaware and Iowa offer it for free, Narcan typically costs money unless you have insurance. The Centers for Disease Control and Prevention recommends that people who use prescription opioids, heroin or a synthetic opioid like fentanyl are prescribed naloxone to keep on hand.
The FDA's move to change Narcan nasal spray to an OTC medication will take time to roll out. The agency said that the rollout may take months, but that it will work with manufacturers to make the drug readily available to retailers and the public.
"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," said FDA Commissioner Robert Califf in a release.