CHARLESTON, W.Va. (WV News) — The U.S. Food and Drug Administration has granted approval for nasal Narcan, the life-saving opioid overdose medication, to be sold without a prescription for the first time.
Gov. Jim Justice, during his briefing Wednesday, said he would support efforts to increase access to the medication throughout the state.
“This just saves lives — that’s all there is to it,” he said. “Anything we could possibly do to make things better and save lives for the people, we need to be out doing it.”
While he said it would ultimately be up to state lawmakers to propose such legislation, Justice indicated he would support a law requiring the medication to be available in schools, churches and other public buildings.
The FDA’s approval is for Narcan’s 4-milligram naloxone hydrochloride nasal spray for over-the-counter, nonprescription use.
This is the first naloxone product approved for use without a prescription.
“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.
“We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
U.S. Sens. Shelley Moore Capito, R-W.Va., and Joe Manchin, D-W.Va., who have previously pushed for over-the-counter availability for naloxone, applauded the FDA’s decision.
“Pleased to see the (FDA) announce approval of first over-the-counter naloxone,” Capito said in a tweet Wednesday morning. “It’s never been more important to adopt opioid overdose prevention and reversal strategies on a wide scale.”
Last year, the two were part of a group of lawmakers who sent letters to several drug manufacturers urging them to apply for over-the-counter status for their respective naloxone products.
“Given the enormous scale of need, it has never been more important to adopt opioid overdose prevention and reversal strategies on a wide scale,” Manchin said in a statement Wednesday afternoon. “Naloxone is an immeasurably valuable resource for our fight against the drug epidemic, and it is proven to be safe and effective for public use.
“I’m thrilled to see the FDA take this meaningful action to make naloxone available over-the-counter, which helps reduce stigma and encourages the widespread use of this critical medication during emergencies.”
According to an FDA press release, Wednesday’s action paves the way for the medication to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.
The timeline for availability and price of the OTC product will be determined by the manufacturer.
The FDA will work with stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only.
Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like fentanyl, according to the FDA.
In 2021, fatal overdoses claimed more than 1,417 West Virginia lives, with 1,201 of those deaths attributed to opioids, according to information from the Centers for Disease Control and Prevention.