FDA shows support for OTC naloxone products

Nov. 17, 2022

The U.S. FDA issued a Federal Register notice this week with the intention of helping to facilitate the development and approval of certain nonprescription opioid-blocking naloxone drug products.

The notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, includes preliminary data showing that certain drug naloxone drug products — up to 4 milligrams nasal spray and up to 2 mg auto injector for intramuscular or subcutaneous use — could be approvable as safe and effective for access without prescription. 

While not a final determination that all Naloxone products are safe over-the-counter and more data is needed on the safety and efficacy of nonprescription use of higher doses and other presentations including vials, such as ampules or syringes without integrated needles, the notice could help improve access to naloxone. 

The move is part of the agency’s FDA Overdose Prevention Framework, which tackles the opioid crisis in the United States. A recent report by the CDC estimated that while U.S. deaths in 2021 increased half as much as in 2020, they are still up 15%. The data showed that overdose deaths involving opioids increased from an estimated 70,029 in 2020 to 80,816 in 2021. 

Just this week, Virginia-based Indivior announced that it would acquire Narcan-developer Opiant Pharmaceuticals in a $145 million deal.