FDA approves first over-the-counter anti-overdose Narcan spray
New York Daily News
The U.S. Food and Drug Administration announced Wednesday that it had approved Narcan for over-the-counter, nonprescription use.
The nasal spray becomes the first naloxone medication to be approved for these uses.
Naloxone, when used in the right timeframe, can rapidly reverse an opioid overdose and is widely considered the standard treatment for opioid overdose.
The spray will soon be available in drug stores, convenience stores, grocery stores and gas stations, as well as online.
“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. 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,” FDA Commissioner Dr. Robert M. Califf said.
According to FDA data, there were more than 100,000 reported fatal overdoses in the U.S. between October 2021 and October 2022. Narcan spray was originally approved by the FDA in 2015.
“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
“The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status. Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”
Narcan can cause symptoms of severe opioid withdrawal, like body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.