The Food and Drug Administration approved Narcan, a naloxone nasal spray, for over-the-counter (OTC), nonprescription use Wednesday morning.
The move makes Narcan the first nonprescription version of naloxone to be approved for use in the fight against the ongoing opioid epidemic in the U.S. The FDA said Narcan can now be sold directly to consumers in places like pharmacies, convenience stores, gas stations and online.
The agency first granted Emergent Biosolutions priority review for Narcan in December. Additionally, it had granted fast-track review for a new drug application for RiVive, a naloxone nasal spray for emergency overdose treatment manufactured by nonprofit pharma Harm Reduction Therapeutics.
The agency said in a media release that all other formulations of naloxone will remain available by prescription only.
FDA Commissioner Robert Califf said in a statement that the agency remains committed to addressing the opioid crisis and is using its regulatory abilities to “facilitate greater access” to Narcan.
“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,” Califf said. “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.”
For more than 20 years, the nation’s opioid and overdose crisis has caused significant damage that has only worsened in recent years.
Overdose deaths in the U.S. have risen more than 17% since 2020, according to an American Medical Association report released in September, with deaths topping 107,000 in 2021. Provisional data released by the Centers for Disease Control and Prevention last May found that overdose deaths have risen by 50% in the past two years.
To address the ongoing crisis, several ad campaigns and public service announcements have targeted consumers to be aware of the risks associated with drug overdoses and for stakeholders to remove barriers to livesaving addiction treatments, like Narcan.
Progress has been made on that front in certain areas. A recently enacted New York state law now requires doctors to prescribe naloxone to some patients on opioid painkillers.
The aforementioned AMA report found barriers to care have hampered the efforts of patient advocates and public health officials to combat the nation’s drug overdose epidemic. As part of the report’s recommendations, the AMA urged states to require payers to make nonopioid pain care alternatives more available and affordable.
On Wednesday afternoon, the AMA released a statement commending the FDA for its decision.
“While government decisions are often incremental, FDA’s decision will transform how we compassionately and logically respond to the overdose epidemic,” Bobby Mukkamala, M.D., chair of the AMA Substance Use and Pain Care Task Force, said in a statement. “More lives will be saved when naloxone is easily available at grocery stores and pharmacies. If it weren’t for naloxone, there would be tens of thousands more Americans dying from opioid overdose, including those related to illicitly manufactured fentanyl.”
Dr. Adam Scioli, medical director and head of psychiatry at Caron Treatment Centers, said he “enthusiastically” supported the FDA’s decision.
“I cannot emphasize enough the importance of keeping naloxone in your home. Carrying Narcan should be like carrying a First Aid Kit or having access to an automatic defibrillator,” Scioli said. “You hope you never need it, but if you do, you will be glad you have it.”
This story has been updated.
