The overdose-reversing drug Narcan may quickly be available for purchase over-the-counter with no prescription, the Meals and Drug Administration introduced Wednesday.
The FDA’s approval of the nasal spray Narcan — the model title for the drug naloxone — means the remedy might be extra extensively out there throughout the U.S. because the nation continues to grapple with an opioid epidemic.
“At this time’s motion paves the way in which for the life-saving remedy to reverse an opioid overdose to be bought on to customers in locations like drug shops, comfort shops, grocery shops and fuel stations, in addition to on-line,” the FDA mentioned in an announcement.
Emergent BioSolutions, the drug firm that produces Narcan, mentioned on Wednesday that it hoped to make the nasal spray out there on retailer cabinets and at on-line retailers by late summer season. It didn’t instantly say how a lot it could value.
“At this time’s landmark FDA OTC approval for Narcan Nasal Spray marks a historic milestone as we’ve delivered on our dedication to make this essential emergency therapy extensively accessible, given the alarming charges of opioid overdoses occurring throughout the nation,” Emergent BioSolutions CEO Robert G. Kramer mentioned in an announcement.
Some states and harm-reduction teams have supplied naloxone without cost to residents. However sometimes those that wished to purchase Narcan needed to get hold of it at a pharmacy with a prescription.
Public well being specialists, harm-reduction advocates and plenty of politicians have argued that these limitations meant fewer folks would get the life-saving remedy they wanted in time.
The FDA approval comes because the U.S. continues to see a staggering variety of opioid-related deaths, pushed largely by the unfold of artificial opioids reminiscent of illicit fentanyl.
In accordance with knowledge from the Facilities for Illness Management and Prevention, there have been 101,751 reported deadly overdoses within the 12-month interval ending in October.
“We will stop overdoses and save lives by making naloxone extra accessible, and on the identical time, we are able to guarantee equitable entry to important well being care,” Well being and Human Providers Secretary Xavier Becerra mentioned in an announcement.
The precise dose accepted for over-the-counter gross sales is the 4 milligram (mg) naloxone hydrochloride nasal spray. Different formulations and dosages of the drug would nonetheless require a prescription, the FDA mentioned.
The administration first accepted Narcan nasal spray in 2015 as a prescription drug.