To encourage drug companies to seek approval for over-the-counter versions of naloxone, an emergency treatment for opioid overdose, the Food and Drug Administration today released model consumer-friendly labels for prospective OTC versions of the drug. FDA-approved versions of naloxone currently require a prescription, which “may be a barrier for people who aren’t under the care of a physician or may be ashamed or even fearful of admitting to issues with substance abuse,” said FDA Commissioner Scott Gottlieb, M.D. Before submitting a new drug application or supplement for an OTC drug product, companies must develop a Drug Facts Label and conduct studies to show that consumers can understand how to use the product without the supervision of a health care professional. “Some stakeholders have identified the requirement to perform these studies as a barrier to development of OTC naloxone products,” Gottlieb said. “To encourage drug companies to enter the OTC market and increase access to naloxone, the FDA took an unprecedented step: we developed a model DFL with easy-to-understand pictograms on how to use the drug. We also conducted label comprehension testing to ensure the instructions were simple to follow.”

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