WASHINGTON — A joint federal panel on Wednesday unanimously recommended to the U.S. Food & Drug Administration that Narcan, the overdose-reversing nasal spray, is safe to sell as an over-the-counter drug.
The panel voted 19-0 after a day of presentations and discussions about whether the drug naloxone should be made available without a prescription, The New York Times reported.
The anti-opioid drug is currently only available through a prescription, according to The Hill. Wednesday’s recommendation, which is not binding, would allow more people to buy nasal spray more easily in more locations.
Breaking News: Narcan, the overdose reversing nasal spray, is safe to sell over the counter without a prescription, two FDA advisory panels recommended. https://t.co/Svpj3g0Wtu
— The New York Times (@nytimes) February 15, 2023
Making Narcan an over-the-counter drug had been recommended by doctors, patient advocacy groups and the Biden administration, The Associated Press reported.
The FDA will make a final decision over the next few weeks, according to the news organization. The projected date for the decision is March 29, The Hill reported.
Millions of doses of Narcan have been administered by emergency responders, health care providers and outreach workers, according to the Times. However, many public health experts believe that if more people had access to the spray at home or in their pockets or purses, many fatalities could be prevented, the newspaper reported.
The panelists decided that naloxone, which was approved as an overdose-reversal injection in 1971, is safe and effective even for infants, the Times reported. They determined that the spray does not require medical training to use.
Several panel members did voice concerns about the drug’s instructions and packaging, the AP reported. The manufacturer, Emergent Biosolutions, said it would revise the packaging and labeling to address those concerns.
Despite their concerns, panel members recommended that the FDA act quickly.
“There’s perhaps a far greater risk of delaying the availability of the product given the climate of this crisis and its devastating consequences,” Maria Coyle, a pharmacy professor from Ohio State University, who chaired the panel, said, according to the AP.
