The Sentinel-Record

FDA panel backs moving opioid antidote Narcan over the counter


WASHINGTON — 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.

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 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.

Emergent said it plans to move all the directions to a single panel and add pictograms, per FDA’s suggestion.

Despite flaws in the original packaging, the panel of 19 pain and medical education experts expressed confidence that the product could be used effectivel­y by most adults and adolescent­s.

“Perfect should not be the enemy of the good and the evidence we saw today provides

clear indication that the drug can be used without the direction of a health care provider,” said Dr. Brian Bateman of Stanford University.

Government officials hope that moving naloxone beyond the pharmacy counter will boost sales, with the potential to lower costs. Currently the drug can cost $50 for a two-pack, when not covered by insurance.

Community advocates and organizati­ons that favor distributi­ng the drug welcomed the potential approval of an overthe-counter version.

“It’s going to make a tremendous impact on how people view the medication,” said Sheila Vakharia, deputy director of research and academic engagement at the Drug Policy Alliance. “It will help to destigmati­ze it and make people know it’s safe and easy to use.”

But Maya Doe-Simkins, a co-director of Remedy Alliance/ For The People, worried that an over-the-counter version of Narcan could also lead to a perception that it’s better than other forms of naloxone.

“We have some trepidatio­n about how companies that have ‘over-the-counter’ products may misreprese­nt injectable products,” said Doe-Simkins, who has long advocated for an overthe-counter version.

U.S. overdose death rates began steadily climbing in the 1990s, driven by painkiller­s. Waves of deaths followed, led by other opioids like heroin and — most recently — illicit fentanyl. Nearly 107,000 Americans died of drug overdoses in 2021, an all-time high, though recent data suggests deaths may be plateauing.

Gaithersbu­rg, Maryland-based Emergent Biosolutio­ns makes most of its money from medical products purchased by the federal government for the Strategic National Stockpile, including drugs and vaccines against anthrax.

In 2021, the company came to the public’s attention for its disastrous handling of COVID-19 vaccine production for Johnson & Johnson and AstraZenec­a. Contaminat­ion problems at the company’s Baltimore plant ultimately forced the drugmakers to discard the equivalent of hundreds of millions of vaccine doses.

Associated Press writer Geoff Mulvihill in Cherry Hill, New Jersey, contribute­d to this story.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educationa­l Media Group. The AP is solely responsibl­e for all content.

 ?? The Associated Press ?? Attendees practice administer­ing Narcan during an overdose education and Narcan training class on Dec. 13, 2021, at the Onala Recovery Center on the South Shore of Pittsburgh.
The Associated Press Attendees practice administer­ing Narcan during an overdose education and Narcan training class on Dec. 13, 2021, at the Onala Recovery Center on the South Shore of Pittsburgh.

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