Jan. 31, 2019 — The FDA has announced “unprecedented” steps to help companies develop over-the-counter (OTC) naloxone to cut 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 make naloxone easier to get. The drug typically can reverse an overdose within minutes when given quickly, said Gottlieb.
To encourage drug companies to bring OTC naloxone to the market soon, the FDA came up with two model “drug facts” labels — one for use with naloxone nasal spray and the other for use with a naloxone auto-injector — and made sure the “consumer-friendly” instructions are simple to follow.
Those are two steps that companies seeking approval of an OTC drug usually have to do themselves. Some companies have said those requirements get in the way of developing OTC naloxone products.
“This is the first time the FDA has proactively developed and tested a DFL [drug facts label] 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; health care providers; patients; and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction,” he said.