FDA yesterday approved Emergent BioSolutions’ Narcan (naloxone hydrochloride) 4 mg nasal spray for OTC use. The action “paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online,” FDA said. The timeline for the availability and price of this OTC product will be determined by the manufacturer, and the switch could take months. FDA said it will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the transition, adding that other formulations and dosages of naloxone will remain available by prescription only. Reporting on the approval, Stat noted that the Narcan product was already available in pharmacies without a prescription because of state exemptions. “But not every pharmacy carries it,” the article notes. “And buyers have to pay for the medication — either with an insurance copay or for the full retail price. The cost varies, but two doses of Narcan often go for around $50.”
In a separate article, Stat reports that “pharmaceutical companies have used the opioid crisis, and the nation’s fear of fentanyl, to aggressively market high-cost naloxone products that divert resources away from cheaper forms of the lifesaving medication. These expensive new products, according to researchers, harm-reduction groups, doctors, and pharmaceutical industry experts, don’t fill a legitimate public health need. Instead, they serve largely as an excuse to charge exorbitant prices for a medication that has been off patent for nearly 40 years.”