Panel backs moving opioid antidote Narcan over the counter

The overdose-reversal drug naloxone should be available as an over-the-counter medication to aid the national response to the opioid crisis, U.S. health advisers said Wednesday.

The expert panel to the Food and Drug Administration voted 19-0 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-formulated drug 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.

The potential move represents the latest government effort to increase use of a medication that has been a key tool in the battle against the U.S. overdose epidemic that kills more than 100,000 people annually. The decades-old drug can counteract the effects of an opioid overdose in minutes.

Narcan is already available without a prescription in all 50 states, where state leaders have issued standing orders for pharmacists to sell the drug to anyone who asks for it. But not all pharmacies carry it and those that do must keep it behind the counter. Also, the stigma of opioids can discourage people from asking for the drug.

“We believe that nonprescription naloxone may help address these barriers,” said FDA's Dr. Jody Green, noting the switch would allow the drug to be sold in vending machines, convenience stores and supermarkets.

Emergent presented results from a 70-person study designed to show that people of various ages and backgrounds could quickly and correctly understand how to use the device in an emergency. About a third of people in the study had low reading ability, a group that FDA said should have been larger.

FDA staffers flagged also cautioned that a number of participants had trouble following the directions, in part because of the way the multi-step instructions were laid out across two sides of the carton, FDA noted.

“Where is step one?” one participant asked, according to interview transcripts from the study presented by the FDA.