Naloxone is a life-saving drug that can stop or reverse the effects of an opioid overdose.
Currently, Naloxone requires a prescription in all 50 states and the District of Columbia.
There are two version of the prescription drug available for use in the community — an auto-injector product for self-injection and a nasal spray version. While both include instructions for use, they do not have the consumer-friendly Drug Facts Label that is required for OTC drug products.
Companies must create this DFL and conduct studies proving consumers can understand how to use the product based on the label’s information before submitting it for approval.
To expedite the process of creating OTC naloxone, the FDA created a model DFL and arranged for label comprehension testing to provide manufacturers with helpful information regarding consumer understanding.
The FDA’s efforts to expand naloxone access stem from the opioid action plan it introduced earlier this year.
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