The U.S. Food and Drug Administration. ?FDA, for its acronym in English? approved the over-the-counter drug Narcan, which includes 4 milligrams of naloxone hydrochloride in a nasal spray, which will no longer require a prescription for its purchase.
Naloxone is a medication that quickly reverses the effects of opioid overdose and is the standard treatment for such incidents.
The agency detailed in a statement that the action paves the way for the life-saving drug to reverse an opioid overdose to be sold directly to consumers in places like pharmacies, convenience stores, supermarkets 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.
FDA will work with all interested parties to help facilitate the continued availability of naloxone nasal spray products during the time necessary to implement Narcan's switch from prescription to over-the-counter, which can take months.
It should be noted that other formulations and dosages of naloxone will remain available only by prescription.
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 the 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 product accessibility 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 label change to currently approved generic naloxone 4 mg nasal spray products that rely on Narcan as their reference pharmaceutical.
Use of Narcan nasal spray in people who are dependent on opioids can lead to 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 tremors, abdominal cramps, weakness, and increased blood pressure.
"Naloxone is a critical tool in addressing opioid overdoses, and today's approval highlights the extensive efforts the agency has made to combat the overdose crisis," said Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research at the FDA.
In turn, he explained that the FDA will work with any sponsor seeking to market a non-prescription naloxone product, including through a change of prescription to over-the-counter, and will encourage manufacturers to contact the agency as soon as possible to start conversations. .
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