The FDA approved Narcan 4 mg nasal spray for nonprescription use on March 29 to combat the ongoing opioid crisis. This approval means the drug will be available over the counter (OTC) in retail stores and online retailers across the nation.
The agency states, however, that other formulations and dosages of the drug will remain prescription-only. Emergent BioSolutions’ Narcan nasal spray is a medication that can reverse the potentially fatal effects of an opioid overdose. These include opioid prescription drug overdoses, heroin and fentanyl overdoses.
According to the FDA, there were 101,750 fatal overdoses involving the synthetic opioid fentanyl during the 12 months ending in October 2022. Moreover, reports indicate that fentanyl-related deaths among children are on the rise, adding fuel to the escalating fentanyl crisis.
Dr. Robert M. Califf, FDA Commissioner, made the announcement. “Today’s approval of over-the-counter naloxone nasal spray will improve access to naloxone, increase the number of locations where it’s available, and help reduce opioid overdose deaths across the country,” says the FDA. “We encourage the manufacturer to make accessibility a priority by making the product available as soon as possible and at an affordable price.”
Emergent BioSolutions says Narcan will be available over-the-counter by late summer, as reported by the Associated Press. Despite the fact that pharmacies can already dispense naloxone without a prescription, it is not yet available in stores. Instead, pharmacists keep the medication behind the counter and require patients to request it, creating additional barriers for patients.
With the FDA’s approval of OTC Narcan, pharmacies and other retailers, such as supermarkets and convenience stores, will be able to stock Narcan on store shelves, making it more accessible to those in need. The availability of Narcan through online retailers will further increase its accessibility.
“The FDA is working with our federal partners to ensure continued access to all forms of naloxone during the transition of this product from prescription to nonprescription/over-the-counter status,” says the director of the FDA’s Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D.
In addition, “we will work with any sponsor seeking to market a nonprescription naloxone product, including through a switch from prescription to over-the-counter status,” and “we encourage manufacturers to contact the agency as soon as possible to begin discussions.”
Still, it is unknown how much Narcan will cost and whether or not insurance will cover it once it becomes commercially available. Until then, in addition to being available behind the counter at pharmacies, the life-saving drug is also provided for free by numerous community organizations in the United States.
