FDA supports greater access to naloxone to help reduce opioid overdose deaths

In an effort to increase access to and use of naloxone, FDA is working on innovative ways to help drug makers seek approval of an OTC naloxone product, writes Karen Mahoney, MD, FDA's Deputy Director, Division of Nonprescription Drug Products, at the Center for Drug Evaluation and Research.

In an effort to increase access to and use of naloxone, FDA is working on innovative ways to help drug makers seek approval of an OTC naloxone product, writes Karen Mahoney, MD, FDA's Deputy Director, Division of Nonprescription Drug Products, at the Center for Drug Evaluation and Research. To that end, the agency has developed a model drug facts label (DFL) and arranged for label comprehension testing of the model DFL. "Using this information, naloxone manufacturers may then be able to focus their final label comprehension testing on how well consumers understand product-specific information, such as instructions for the device that delivers naloxone that has not been already tested on the model DFL," Mahoney writes. The agency will continue to work with interested companies to further explore the best uses of naloxone for the emergency treatment of known or suspected overdoses until emergency medical assistance is available.