FDA approves first over-the-counter naloxone nasal spray

The US FDA has approved Narcan, a nasal spray containing 4 milligrams of naloxone hydrochloride, for over-the-counter (OTC) use. This is the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose, and is the standard treatment for opioid overdose. This approval means that the life-saving medication will be available directly to consumers in places such as drug stores, convenience stores, grocery stores, gas stations, and online.

“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 Robert M. Califf, MD, in a press release. “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 approved narcan nasal spray in 2015 as a prescription drug.

Read the full press release here.