The U.S. Food and Drug Administration (FDA) is taking unprecedented steps to support the development of over-the-counter naloxone to reverse the effects of opioids in an effort to reduce opioid overdose deaths.
“With the number of overdose deaths involving prescription and illicit opioids more than doubling over the last seven years to nearly 48,000 in 2017, it’s critical that we continue to address this tragedy from all fronts,” FDA Commissioner Scott Gottlieb, M.D., said in a statement.
When someone overdoses on opioids, they can lose consciousness and their breathing may become shallow or stop altogether, which can quickly lead to death if there is no medical intervention. Naloxone can save lives if it is administered quickly.
“The bottom line is that wider availability of naloxone and quick action to administer it can save lives,” Gottlieb said. Which is why the agency is taking action to increase the availability of naloxone for emergency treatment of overdoses.
Currently, FDA-approved versions of naloxone require a prescription, which may be a barrier for people who are not under the care of a physician or may feel too ashamed or embarrassed to admit having a problem with substance abuse, Gottlieb said.
But an OTC version cannot be marketed without proper labeling and the blessing of the FDA. To encourage companies to quickly bring OTC naloxone to the market, the FDA has developed easy-to-understand “drug facts” label (DFL) models for companies to follow. Companies that want to get approval for an OTC naloxone product must develop a DFL and conduct studies to demonstrate that the instructions are easy to comprehend.
“This is the first time the FDA has proactively developed and tested a DFL for a drug to support development of an OTC product,” Gottlieb said.