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FDA Approves First Over-the-Counter Naloxone Spray

The U.S. Food and Drug Administration (FDA) today approved Narcan, 4 mg. naloxone hydrochloride nasal spray for over-the-counter (OTC), non-prescription use, making it the first naloxone product approved to use without a prescription.

Naloxone is a medication that reverses the effects of opioid overdose rapidly and is the standard treatment for opioid overdose. The FDA’s action today clears the way for this life-saving medication to be sold directly to consumers in drug stores, convenience stores, grocery stores, gas stations, and online.

The move comes at a time when the Centers for Disease Control and Prevention released provisional data this month that showed 101,751 reported U.S. fatal overdoses in the 12-month period ending in October 2022, while the predicted number of fatal doses for that period is even higher at 107,689.

“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,” FDA Commissioner Robert M. Califf, M.D said in today’s announcement. “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.”

According to the FDA, the manufacturer determines the timeline for availability and price of this OTC product. Click here to learn more.