The U.S. Food and Drug Administration The FDA approved the over-the-counter sale of the drug Narcan, which includes 4 milligrams of naloxone hydrochloride in nasal spray, meaning that a prescription will no longer be required for its purchase.
Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for such incidents.
The agency said in a statement that the move paves the way for the life-saving opioid overdose-reversing drug to be sold directly to consumers in places like pharmacies, convenience stores, grocery stores and gas stations, as well as online.
The timeframe for availability and pricing of this over-the-counter product is determined by Emergent BioSolutions, who is the manufacturer of Narcan.
The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the shift of Narcan from prescription to over-the-counter, which may take months.
It should be noted that other formulations and dosages of naloxone will remain available by prescription only.
Drug overdose remains a major public health problem in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending October 2022, driven primarily by synthetic opioids such as illicit fentanyl.
“Today’s approval of over-the-counter naloxone nasal spray will help improve access to naloxone, increase the number of places where it is available, and help reduce opioid overdose deaths across the country. We encourage the manufacturer to make accessibility of the product a priority by making it available as soon as possible and at an affordable price,” said FDA Commissioner Robert M. Califf.
Narcan nasal spray was first approved by the FDA in 2015 as a prescription medication.
Approval of over-the-counter Narcan nasal spray will require a change in the labeling of currently approved generic 4 mg naloxone nasal spray products that rely on Narcan as their reference drug product.
Use of Narcan nasal spray in people who are opioid dependent may cause severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, chills or shaking, abdominal cramps, weakness, and increased blood pressure.
“Naloxone is a critical tool in addressing opioid overdoses, and today’s approval highlights the agency’s extensive efforts to combat the overdose crisis,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
The FDA will work with any sponsor seeking to market a non-prescription naloxone product, including through a switch from prescription to over-the-counter, and will encourage manufacturers to contact the agency as soon as possible to begin discussions, he said.
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