FDA panel unanimously supports over-the-counter sale of opioid antidote

WASHINGTON. The overdose prevention drug naloxone should be available without a prescription to help the national response to the opioid crisis, U.S. health advisers said Wednesday.

A panel of experts from the Food and Drug Administration voted unanimously in favor of the transition after a full day of presentations and discussions on whether untrained users would be able to safely and effectively use nasal spray in emergency situations.

The positive vote, which is non-binding, came despite concerns from some panel members about the drug’s instructions and packaging, which caused confusion among some of the company’s study participants. Manufacturer Emergent Biosolutions said it will review packaging and labeling to address these concerns. The FDA will make a final decision on the drug in the coming weeks.

Panel members urged the FDA to act quickly rather than wait for Emergent to conduct a follow-up study with a clearer label.

“There may be a much greater risk of delaying product availability given the climate of this crisis and its devastating impact,” said Maria Coyle, a pharmacy professor at Ohio State University who led the team.

Narcan’s pre-filled nasal device is the leading version of the drug in the US, which is also available as an injection. If the Food and Drug Administration approves, Narcan will be the first opioid drug to switch to an over-the-counter drug.

The potential move represents the government’s latest attempt to increase use of the drug, which has been a key tool in the fight against the U.S. overdose epidemic that kills more than 100,000 people every year. A drug with a long history can reverse 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 to pharmacists to sell the drug to anyone who asks for it. But not all pharmacies have it, and in those that do, it should be kept behind the counter. In addition, the stigmatization of opioids can discourage people from asking for the drug.

“We believe that over-the-counter naloxone can help remove these barriers,” said Dr. Jody Green of the FDA, noting that the transition would allow the drug to be sold in vending machines, convenience stores and supermarkets.

Emergent presented the results of a study involving 70 people, designed to show that people of different ages and backgrounds can quickly and correctly understand how to use the device in an emergency. About a third of the people in the study had poor reading ability, and that group, according to the FDA, should have been larger.

FDA officials also warned that a number of participants had trouble following the instructions, in part because the multi-step instructions were located on two sides of the box, the FDA said.

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

Emergent said it plans to move all referrals to one panel and add pictograms as suggested by the FDA.

Despite the defects in the original packaging, a panel of 19 pain relief and health education experts expressed confidence that the product can be used effectively by most adults and adolescents.

“Perfect shouldn’t be the enemy of good, and the evidence we’ve seen today clearly indicates that the drug can be used without the direction of a healthcare provider,” said Dr. Brian Bateman of Stanford University.

Government officials hope that moving naloxone off the drugstore shelves will boost sales and lower costs. Currently, the drug can cost $50 for two packs if not covered by insurance.

Public defenders and pro-distribution organizations have welcomed the potential approval of an over-the-counter version.

“This will have a huge impact on how people feel about the drug,” said Sheila Vakharia, associate director of research and academic affairs at the Drug Policy Alliance. “This will help de-stigmatize it and let people know it’s safe and easy to use.”

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

“We have some concerns that OTC companies may be misrepresenting injectable products,” said Dow-Simkins, who has long advocated an OTC version.

Overdose deaths in the US began to rise steadily in the 1990s, aided by painkillers. Waves of death followed, led by other opioids such as heroin and, more recently, illicit fentanyl. Nearly 107,000 Americans have died from drug overdoses in 2021, a record high, although recent data suggests the death toll may stabilize.

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

In 2021, the company garnered public attention for its disastrous handling of COVID-19 vaccine production for Johnson & Johnson and AstraZeneca. Contamination problems at the company’s Baltimore plant eventually forced drug makers to abandon the equivalent of hundreds of millions of doses of the vaccine.