In a 19-0 vote on Feb. 15, an FDA advisory panel recommended the agency allow Narcan (naloxone) nasal spray, a product used to reduce or reverse opioid overdoses, to be sold over the counter.
The drug is decades old, and its intranasal option was first approved in 2015. The committee members said their greenlight votes were based on access barriers, the thousands of Americans who die every year from opioids and the low risk of errors.
The drugmaker Emergent BioSolutions filed the nonprescription application, according to the committee's briefing document.
"It's a huge public health benefit and it's way overdue," one panelist said.
The FDA is scheduled to make the final vote by March 29.