WASHINGTON – The overdose drug naloxone should be available over the counter to help the nation’s response to the opioid crisis, U.S. health advisers said Wednesday.
A Food and Drug Administration panel of experts voted unanimously in favor of the move after a full day of presentations and discussions on whether untrained users could safely and effectively use the nasal spray in an emergency.
The affirmative vote, which is not binding, came despite concerns from some panel members about the drug’s instructions and packaging, which has caused confusion among some people in the company’s research. The manufacturer, Emergent Biosolutions, said it would revise the 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 more quickly, rather than waiting 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 effects,” said Maria Coyle, an Ohio State University pharmacy professor who chaired the panel.
Narcan, a pre-filled nasal device, is the leading version of the drug in the US, and is also available as an injection. If approved by the FDA, Narcan will be the first opioid treatment to go over the counter.
The potential move represents the latest attempt by the government to increase the use of the drugs, which are a key tool in the fight against the overdose epidemic in the US, which kills more than 100,000 people each year. The drug, which has been around for decades, can reverse the effects of an opioid overdose in minutes.
Narcan is already available over the counter in all 50 states where state leaders have issued orders for pharmacists to sell the drug to anyone who asks for it. But not all pharmacies have it, and those that do have it, should keep it behind the counter. Additionally, opioid stigma can prevent people from asking for the drug.
“We believe that over-the-counter naloxone can help break down these barriers,” said Dr. Jody Green of the FDA, noting that the move would allow the drug to be sold in vending machines, convenience stores and supermarkets.
Emergent presented the results of a study involving 70 people, which aimed 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 study participants had poor reading ability, and this group, according to the FDA, should have been larger.
FDA officials also warned that some participants had trouble following the instructions, in part because of the way the step-by-step instructions were laid out on two sides of the carton, the FDA said.
“Where’s the first step?” asked one participant, according to an interview transcript from the study provided to the FDA.
Emergent said it plans to move all labeling to a single panel and add icons as suggested by the FDA.
Despite the flaws in the original packaging, a panel of 19 experts in pain relief and medical education expressed confidence that the product can be effective for most adults and adolescents.
“Perfect should not be the enemy of good, and the evidence we saw today clearly suggests that the drug can be used without a health care provider’s prescription,” said Dr. Brian Bateman of Stanford University.
Government officials hope that moving naloxone off the pharmacy counter will increase sales and potentially lower costs. Currently, the drug can cost $50 for a two-pack if not covered by insurance.
Advocates and drug advocacy groups have welcomed the potential approval of an over-the-counter version.
“It’s going to have a huge impact on how people view drugs,” said Sheila Vaharia, associate director of research and academic affairs at the Drug Policy Alliance. “It will help destigmatize it and let people know it’s safe and easy to use.”
But Maya Dow-Simkins, co-director of Remedy Alliance/For The People, worries that the over-the-counter version of Narcan could also lead to the perception that it’s better than other forms of naloxone.
“We have some concerns about how companies that sell over-the-counter products can misrepresent injectable products,” said Dow-Simkins, who has long advocated for an over-the-counter version.
Overdose deaths in the US began to rise steadily in the 1990s, driven by painkillers. Waves of deaths followed, led by other opioids such as heroin and – most recently – the banned fentanyl. Nearly 107,000 Americans died of drug overdoses in 2021, an all-time high, although recent data suggest the death toll may be rising.
Emergent Biosolutions, based in Gaithersburg, Md., makes most of its money from medical products the federal government buys for the Strategic National Stockpile, including anthrax drugs and vaccines.
In 2021, the company gained public attention for Johnson’s disastrous management of the production of the COVID-19 vaccine & Johnson and AstraZeneca. Contamination problems at the company’s Baltimore plant ultimately forced drugmakers to abandon the equivalent of hundreds of millions of vaccine doses.
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Associated Press writer Jeff Mulvihill in Cherry Hill, N.J., contributed to this story.
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