FDA: Over-the-counter naloxone ‘may be approvable’

The FDA announced findings from a preliminary assessment that indicate certain naloxone products may be safely used without a prescription to prevent opioid overdose deaths.

Specifically, the agency said in a Federal Register notice that nasal spray (up to 4 mg) and autoinjector (up to 2 mg) naloxone products “may be approvable as safe and effective” for over-the-counter use.

“We believe the prescription requirement for these naloxone products might not be necessary for the protection of the public health,” the FDA said. “However, we need additional data such as product-specific data on the nonprescription user interface design, including packaging and labeling, to make a conclusive determination in this respect.”

The FDA said that the Federal Register notice may help facilitate the development and approval of over-the-counter naloxone products, including through switching certain FDA-approved products from prescription to nonprescription status.

“The agency strongly encourages application holders of prescription naloxone products described in this notice to contact FDA as early as possible to initiate a discussion about a possible switch,” the FDA said.

More than 80,000 people in the United States died from an opioid-involved overdose in the 12-month period ending in January, according to the FDA, “representing 75% of all drug overdose deaths.”

“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” FDA Commissioner Robert M. Califf, MD, said in a press release. “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible.”

The Federal Register notice is the latest step that the FDA has taken to improve access to naloxone products. Previous efforts include the creation of a model Drug Facts Label, which the FDA said is required for over-the-counter drugs. The label includes “easy-to-understand pictograms on how to use the drug to encourage manufacturers to pursue approval of OTC naloxone products; requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder to add new recommendations about naloxone to their prescribing information; and extending the shelf life of naloxone nasal spray from 24 months to 36 months,” according to the release.

The FDA also issued guidance on requirements for bulk naloxone purchases, allowing manufacturers to provide the product directly to harm-reduction organizations, according to the AMA. In a press release, Bobby Mukkamala, MD, chair of the AMA Substance Use and Pain Care Task Force, said the AMA encourages providers “to prescribe naloxone to patients at risk of overdose and to others who may be able to save a life from unintentional overdose while waiting for naloxone to become available over the counter.”

References:

FDA announces preliminary assessment that certain naloxone products have the potential to be safe and effective for over-the-counter use. https://www.fda.gov/news-events/press-announcements/fda-announces-preliminary-assessment-certain-naloxone-products-have-potential-be-safe-and-effective. Published Nov. 15, 2022. Accessed Nov. 15, 2022.

FDA naloxone guidance helps harm-reduction groups’ work to save lives. https://www.ama-assn.org/delivering-care/overdose-epidemic/fda-naloxone-guidance-helps-harm-reduction-groups-work-save-lives. Published Nov. 10, 2022. Accessed Nov. 15, 2022.

Safety and effectiveness of certain naloxone hydrochloride drug products for nonprescription use. https://public-inspection.federalregister.gov/2022-24874.pdf. Published Nov. 15, 2022. Accessed Nov. 15, 2022.