Advisory panel votes to approve naloxone over-the-counter sale

Feb. 15 (UPI) -- Independent advisers recommended Wednesday that the U.S. Food and Drug Administration approve over-the-counter sales of naloxone, which is commonly used to reverse opioid overdoses.

The FDA's advisory panel made the unanimous recommendation during a joint meeting between the Anesthetic and Analgesic Drug Products Advisory Committee and Nonprescription Drugs Advisory Committee.

Naloxone is sold under the brand name Narcan and is commonly administered through a nasal spray to counteract the effects of an overdose brought on by opioid use.

If given final approval by the FDA at the end of March, it would significantly expand access to the treatment, making it available at hundreds of pharmacies.

Several pharmacies already have blanket prescriptions allowing them to sell the drug, which was patented in 1961.

Naloxone is on the World Health Organization's list of essential medicines and typically works for 30 to 90 minutes after administration. Responders are taught to give an overdose victim a dose of the easy-to-use nasal spray before calling 911.

Currently, 28 U.S. states offer immunity from civil liability, criminal liability and professional disciplinary actions to people who use or make naloxone available.

Naloxone prescriptions in the United States reached 1.5 million in 2021, the FDA said Wednesday.

Narcan is manufactured by Opiant Pharma based in Santa Monica, Calif. Its licensee, Emergent BioSolutions, produces the nasal spray distributed in the United States and Canada.

"We have been working on distribution plans with key stakeholders like retailers and government leaders," Matt Hartwig, a spokesman for Maryland-based Emergent BioSolutions, told NBC.

The company said the drug would be available over the counter late this coming summer if the proposal receives final FDA approval. The FDA typically follows the recommendations of its independent advisory panels, although it is not required to do so.

"There is no reason to keep this as a prescription. Let's get it out there and save some lives," Nonprescription Drugs Advisory Committee patient representative Elizabeth Coykendall said Wednesday.