FDA takes steps to make naloxone OTC

FDA announced that it’s moving forward to remove barriers and make it easier for drug manufacturers to develop naloxone OTC. FDA Commissioner, Scott Gottlieb, MD, said the effort is part of an overall strategy to increase access to the opioid overdose antidote and reduce opioid overdose deaths. 

FDA announced that it’s moving forward to remove barriers and make it easier for drug manufacturers to develop naloxone OTC. FDA Commissioner, Scott Gottlieb, MD, said the effort is part of an overall strategy to increase access to the opioid overdose antidote and reduce opioid overdose deaths. 

"Having naloxone widely available, for example as an approved OTC product, is an important public health advance, and a need that we've been working on at the FDA," Gottlieb said in a written statement.

In order to encourage manufacturers to enter the OTC naloxone market, Gottlieb said FDA developed and tested two Drug Facts Labels (DFLs): one for use with a nasal spray and one for use with an auto-injector. "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," Gottlieb said. "In short, we've crafted model labeling that sponsors can use to obtain approval for OTC naloxone and increase its access." The DFL features easy-to-understand pictograms on how to use naloxone, and FDA also conducted label comprehension testing to make sure the instructions were easy to follow.