The overdose-reversing drug naloxone should be made available over the counter to aid the national response to the opioid crisis, U.S. health advisers said Wednesday.
The panel of Food and Drug Administration experts voted unanimously in favor of the switch after a full day of presentations and discussions centered on whether untrained users would be able to safely and effectively use the nasal spray in emergency situations.
The positive vote, which is not binding, came despite concerns from some panel members about the drug’s instructions and packaging, which caused confusion among some people in a company study. The manufacturer, Emergent Biosolutions, said it would revise the packaging and labeling to address those concerns. The FDA will make a final decision on the drug in coming weeks.
Panel members urged the FDA to move swiftly rather than waiting for Emergent to conduct a follow-up study with the easier-to-understand label.
“There’s perhaps a far greater risk of delaying the availability of the product given the climate of this crisis and its devastating consequences,” said Maria Coyle, a pharmacy professor from Ohio State University, who chaired the panel.
The prefilled nasal device, Narcan, is the leading version of the drug in the U.S., which is also available as an injection. If FDA approves, Narcan would be the first opioid treatment to make the regulatory switch to a non-prescription drug.