Washington (WBAP/KLIF) – The U.S. Food and Drug Administration on Wednesday approved selling 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.
The approved branded 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.
ADVERTISEMENT
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.
Police and other first responders also often carry it.
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.
The nonprofit Harm Reduction Therapeutics Inc., which has funding from OxyContin maker Purdue Pharma, has an application before the FDA to distribute its version of spray naloxone without a prescription.
