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Friday, March 31, 2023

Over-the-counter Narcan will save lives by stopping drug overdoses. It'll be available this fall; price remains a hurdle.

Doses of Narcan brand of naoloxone in a vending machine
(Photo by Erin Schaff, The New York Times)
Every first-aid kit and family medicine box will need this: Narcan. That's the brand name of a prescription nasal spray, naloxone, that reverses opioid overdoses. The Food and Drug Administration approved the medication for over-the-counter sales, a move long sought by public-health officials and treatment experts, reports Jan Hoffman of The New York Times. "With overdoses and overdose fatalities occurring in college dorms, public libraries, households, night clubs and restaurants, public-health advocates hope that naloxone nasal sprays will soon become a staple. . . . By late summer, over-the-counter Narcan is expected to be for sale in big-box chains, supermarkets, convenience stores, gas stations and online retailers. New York City plans to install Narcan vending machines later this year."

Narcan is easy to give, works quickly, and has no adverse side effects. Hoffman explains, "Bystanders who see that a person slumped over is unresponsive to shaking and shouting, with slowed breathing — signs of a possible overdose — only have to unwrap the palm-size device, insert the tip into the person's nostril and depress the plunger. In most situations, the medication revives the person within two or three minutes. . . . Narcan will not work if the person has taken nonopioid drugs like methamphetamines or xylazine, an animal tranquilizer that has been infiltrating street drug supplies."

Price could be a hurdle. "Although over-the-counter status will make Narcan more widely available, the cost of the medicine could deter many. Currently, a two-dose pack of prescription Narcan is often free to people covered by Medicaid or private insurance or has a co-pay of less than $10," Hoffman reports. "But public and private insurance programs do not cover most over-the-counter medicines. Whether an exception will be made for Narcan could take months to resolve," Hoffman writes, "The company that makes Narcan, Emergent BioSolutions, declined to disclose the price it plans for an over-the-counter version, which will take several months to relabel and repackage."

The FDA is aware of the cost barrier, and is "urging other manufacturers of prescription naloxone to apply for over-the-counter approval, which could make pricing more competitive," Hoffman reports. Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, told Hoffman, "We will work with any sponsor seeking to market a nonprescription naloxone product. . . . [they urged manufacturers] to contact the agency as early as possible to initiate discussions."

Dennis Cauchon, president of Harm Reduction Ohio, a nonprofit group that distributes free naloxone doses, told Hoffman: "All naloxone should have been moved over the counter. . . . Now you have the expensive version available without a prescription, but the cheaper versions need a prescription. It's important that the brand name Narcan be priced much lower over the counter than it is now. The price needs to be less than $30 for a two-dose kit, preferably much lower."

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