The U.S. Food and Drug Administration (FDA) on Wednesday approved selling the leading version of naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter.
It’s a move that some advocates have long sought as a way to improve access to a life-saving drug, though the exact impact will not be clear immediately.
Here’s a look at the issues involved.
What Is Narcan?
The approved nasal spray from Gaithersburg, Maryland-based Emergent BioSolutions is the best-known form of naloxone.
It can reverse overdoses of opioids, including street drugs such as heroin and fentanyl and prescription versions including oxycodone.
Making naloxone available more widely is seen as a key strategy to control the nationwide overdose crisis, which has been linked to more than 100,000 U.S. deaths a year. The majority of those deaths are tied to opioids, primarily potent synthetic versions such as fentanyl that can take multiple doses of naloxone to reverse.
The drug has been distributed to police and other first responders nationwide.
Advocates believe it’s important to get naloxone to the people who are most likely to be around overdoses, including people who use drugs and their relatives.
The decision “represents a decisive, practical, and humane approach to help people and flatten the curve of overdose deaths,” said Chuck Ingoglia of the National Council for Mental Wellbeing, in a statement.
What Does the FDA Approval Mean?
Narcan will become available over-the-counter by late summer, the company said.
Other brands of naloxone and injectable forms will not yet be available over the counter, but they could be soon.
Several manufacturers of generic naloxone that’s made similarly to Narcan will now be required to file applications to switch their drugs over the counter as part of a requirement by the FDA.
