In Unprecedented Step, FDA Issues Over-the-Counter Naloxone Labels

On Wednesday, the U.S. Food and Drug Administration (FDA) issued two model consumer-friendly drug facts labels (DFLs) for over-the-counter naloxone products. Currently, FDA-approved versions of naloxone require a prescription from a medical provider, posing a barrier to individuals who may be at risk of an opioid overdose. The FDA is currently engaged in activities to make naloxone more widely available, including having naloxone approved as an over-the-counter (OTC) product.

FDA-approved prescription naloxone products currently have instructions for use in product labeling, but they do not currently have consumer-friendly DFLs – a requirement for OTC products. As part of the application for an OTC drug product, pharmaceutical companies must develop a DFL and conduct studies to demonstrate that consumers can clearly understand how to use the product without supervision by a health care provider. Through stakeholder processes, FDA learned that the requirement to develop and test these DFLs are a barrier to the development of OTC naloxone products.

Citing these barriers and the urgent need to make naloxone more widely available in the face of the nationwide opioid epidemic, FDA Commissioner Scott Gottlieb in a statement indicated this is the first time the FDA has proactively developed and tested a DFL for a drug to support development of an OTC product. The move is expected to make it easier for pharmaceutical companies to enter the OTC market with naloxone products and increase access for consumers who may be at risk of opioid overdose.

The two consumer-friendly DFL models are now available for nasal spray naloxone products and for auto-injector naloxone products. The FDA continues to build on efforts to address the nationwide opioid epidemic, including activities to improve addiction prevention, enhance treatment and recovery services, and strengthen data and research. Additional information on the FDA’s action on OTC labels is available here.