The Food and Drug governance's historic decision to allow over-the-counter (OTC) sales of naloxone marks a pivotal moment in the fight against opioid overdose deaths. This expanded access promises to put a life-saving medication directly into the hands of those who need it most, but also raises questions about implementation and public health education.
On August 30, 2023, the Food and Drug Administration approved Narcan, a naloxone nasal spray manufactured by Emergent BioSolutions, for over-the-counter sale. This is the first time a life-saving opioid overdose reversal medication has been made available without a prescription in the United States. The approval was based on decades of data demonstrating naloxone's safety and efficacy, and the FDA steadfast that consumers can understand how to administer the spray correctly.
The FDA's decision follows a proposed rule issued earlier this year, seeking public comment on a framework for broader OTC naloxone access. The agency cited the urgent need to address the escalating opioid crisis, which claimed over 80,000 lives in the United States in 2022, according to the Centers for Disease Control and Prevention (CDC).