The FDA on Wednesday approved Narcan, an opioid overdose reversal drug, to be sold without a prescription.
The approval marks the first time any form of naloxone will be available without a prescription. The drug, which first received FDA approval in 1971, was originally an injection. The FDA approved the inhaled nasal spray version, more commonly known as Narcan, in 2015. It contains 4 mg of naloxone that can be sprayed into the nose like a common allergy medication.
“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,” FDA Commissioner Robert Califf said in a statement.
Emergent BioSolutions, which makes the drug, estimates that it would begin commercializing OTC Narcan by late summer.