FDA Approves First Over-The-Counter Opioid Overdose Treatment
By Jason Hall
March 29, 2023
The first ever over-the-counter version of the opioid overdose reversal drug nalaxone, sold by Emergent BioSolutions under the brand Narcan, was approved by the U.S. Food and Drug Administration on Wednesday (March 29) in an effort to increase access to the lifesaving drug, NBC News reports.
Naloxone, which is commonly found at community centers, local health departments and needle exchange programs, had only been available for purchase as a prescription drug prior to Wednesday's decision.
"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," said FDA Commissioner Dr. Robert Califf in a statement obtained by NBC News.
Dr. Scott Hadland, a pediatrician and addiction specialist at MassGeneral Hospital for Children in Boston, said the decision to approve an over-the-counter version of Narcan could increase the amount of lives saved in relation to drug overdoses.
“Narcan can save a life in minutes, which is critical,” Hadland said via NBC News.
An advisory committee to the FDA unanimously recommended that an over-the-counter version of the drug be approved just over a month prior to Wednesday's decision. Drug overdoses were the most common cause of accidental deaths in the United States with more than 107,000 reported in 2021, which included more than 80,000 in relation to opioids, according to data shared by the U.S. Centers for Disease Control and Prevention.