03/20/2023 By Peyton Benbow
On Wednesday, the Food and Drug Administration approved an over-the-counter version of naloxone hydrochloride, the standard drug for opioid overdose treatment and reversal.
The naloxone drug “Narcan,” made by biopharmaceutical company Emergent Biosolutions, has been available in the U.S. since its approval as a prescription drug in 2015. Now, Narcan will be the first of its kind to be sold directly to consumers as an OTC drug in a single-dose nasal spray.
This decision follows an advisory board to the FDA’s urges last month to make a naloxone nasal spray readily available to the public. Their recommendation comes in response to the prevalence of the illicit fentanyl and synthetic opioid markets. The CDC reported that of those who died of a drug overdose in the twelve months after January 2022, 75% of those deaths involved at least one opioid.
FDA officials note that the switch of Narcan from a prescription to an OTC drug may take several months, and it will likely be fully available for purchase in the late summer. In many cases, Narcan is already available in local communities and health centers to combat the opioid crisis. The FDA plans to put the OTC version in grocery stores, convenience stores, and possibly vending machines to maximize accessibility.
The manufacturers of Narcan, Emergent, have declined to share any cost; and the FDA stated that the price of OTC naloxone will be determined by the companies that make it. Online, the current mean price of prescription double-dose Narcan is $53.99, according to GoodRx. The OTC version will be sold as a single spray dose.
In the FDA’s statement on Wednesday, they encouraged other naloxone manufacturers to switch from prescription to over-the-counter availability. The director of the FDA’s Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., said in their press release: “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.” As Narcan is the first naloxone drug to make the switch, other pharmaceutical companies are expected to follow this initiative by Emergent Biosolutions.