FDA Moves to Fast-Track OTC Naloxone for Opioid Overdose

Megan Brooks

January 17, 2019

The US Food and Drug Administration (FDA) today announced "unprecedented" steps to support companies in developing over-the-counter (OTC) naloxone to help reduce opioid overdose deaths.

"With the number of overdose deaths involving prescription and illicit opioids more than doubling over the last 7 years to nearly 48,000 in 2017, it's critical that we continue to address this tragedy from all fronts," FDA Commissioner Scott Gottlieb, MD, said in a statement.

This includes new ways to increase availability of naloxone, which typically can counter the overdose effects within minutes when administered quickly, said Gottlieb.

To encourage drug companies to quickly bring OTC naloxone to the market, the FDA developed two model "drug facts" labels — one for use with naloxone nasal spray and the other for use with a naloxone auto-injector — and conducted extensive testing to ensure the "consumer-friendly" instructions are simple to follow.

Companies seeking approval of an OTC product are required to develop a drug facts label (DFL) and conduct studies to demonstrate that consumers can understand how to use the product. Some companies have identified the requirement to perform these studies as a barrier to development of OTC naloxone products.

"This is the first time the FDA has proactively developed and tested a DFL for a drug to support development of an OTC product," said Gottlieb. "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," he noted.

"These efforts should jump-start the development of OTC naloxone products to promote wider access to this medicine," said Gottlieb.

"We're taking many steps to improve availability of naloxone products and we're committed to working with other federal, state, and local officials; healthcare providers; patients; and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction," added Gottlieb.

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