Narcan—an overdose-reversing medication sold by Emergent BioSolutions—is expected to hit the shelves across the US later this year as the first prescription-strength naloxone nasal spray approved for over-the-counter (OTC) use.
FDA officials approved the drug’s OTC designation on Wednesday, allowing the sale of 4 milligram Narcan nasal spray nationwide without a prescription. The medication is expected to be available at retailers (including online) “by the late summer,” according to Emergent BioSolutions.
FDA Commissioner Robert Califf said in a statement that the new designation “will help improve access to naloxone, increase the number of locations where it’s available, and help reduce opioid overdose deaths throughout the country.” The US reported almost 102,000 fatal overdoses between October 2021 and October 2022, largely driven by illicit fentanyl.
Califf encouraged the drug’s manufacturer “to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Emergent BioSolutions spokesperson Matt Hartwig said the company isn’t discussing the drug’s expected price “at this time.”
“We are in active discussions with retail partners to expand access to Narcan through multiple channels,” he told Healthcare Brew. “Since acquiring the product, Emergent has not raised the price of Narcan and provides discounts to public interest groups like community-based organizations, harm reduction groups, fire departments, [and] law enforcement—in addition to donating thousands of units of Narcan—to help provide underserved populations with access.”
Sandeep Kapoor, assistant VP of emergency medicine for addiction services at New York-based Northwell Health, told Healthcare Brew that the cost for the OTC medication will likely affect how widely it will be used—and ultimately the number of fatal overdoses.
“The price point is going to really matter,” he said. “If we put something out there that’s going to be $100, then I’m sure the utilization of this regulation change is going to be low.”
Some health economists have predicted that the new price could be $35–$65, not including retailer markups, the New York Times reported.
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Northwell, through a partnership with New York State, has distributed more than 11,000 naloxone rescue kits. Several community-based organizations, local health departments, and civic groups across the US also provide Narcan and Narcan training for free.
Every state has enacted laws to let people obtain naloxone. New York, for example, has a standing order that allows naloxone to be sold without a prescription at pharmacies to those who request it, though that requires the drug to be kept behind the counter (BTC). Those BTC sales can be easier for people with health insurance to take advantage of because insurers can help cover the drug’s costs, Kapoor argued.
“If someone doesn’t have insurance, then there is a substantial cost to that individual—even [if] they have a prescription or not,” he said. “This new change will allow people, just like any other over-the-counter medications, to pick it off the shelf and purchase it without going through all these different logistics and worrying about having insurance.”
FDA officials said the agency will “work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status.” Other formulations and dosages of the medication will remain available only with a prescription.
Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, however, said in a statement that the agency “will work with any sponsor seeking to market a nonprescription naloxone product, including through a prescription to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”
On Wednesday, the American Medical Association called for all makers of naloxone to submit over-the-counter applications, arguing “there is no ethical reason for other manufacturers to delay.”