FDA Commissioner Scott Gottlieb has issued a statement detailing steps that the agency is taking to encourage development of an over the counter naloxone nasal spray, including the publication of a model drug facts label (DFL). Gottlieb said, “I personally urge companies to take notice of this pathway that the FDA has opened for them and come to the Agency with applications as soon as possible.”
The agency has never before taken such a step, Gottlieb noted, explaining that “We proactively designed, tested and validated the key labeling requirements necessary to approve an OTC version of naloxone and make it available to patients. One of the key components for OTC availability is now in place. In short, we’ve crafted model labeling that sponsors can use to obtain approval for OTC naloxone and increase its access.”
The agency has already conducted label comprehension testing of the model DFL, which it notes includes “easy-to-understand pictograms on how to use the drug.” The label also includes easy-to-read instructions such as, “yell ‘Wake Up!'” and “insert in NOSE and press” and a warning that “When using this product some people may experience symptoms when they wake up, such as shaking, sweating, nausea, or feeling angry. This is to be expected.”
A model DFL for an OTC naloxone auto-injector was also published. Gottlieb noted that the product-specific instructions in each model version of the DFL “are placeholders that have not been tested by the FDA for comprehension or human factors performance” and can be replaced by sponsors with more specific instructions for a particular device.
Label comprehension testing was conducted by a contractor and involved more than 700 people representing various groups that might need to use OTC naloxone, including heroin and prescription opioid users, friends and family of drug users, and teenagers. After reviewing the study results, the FDA concluded that “the model DFL was well-understood by consumers and is acceptable for use by manufacturers in support of their OTC naloxone development programs.”
Read the FDA press release.
