WASHINGTON (AP) — The overdose reversal drug naloxone should be made over-the-counter to aid the national response to the opioid crisis, U.S. health advisers said Wednesday.
The Food and Drug Administration’s panel of experts voted unanimously for the switch after a full day of presentations and discussions about whether untrained users could safely and effectively use the nasal spray in emergency situations.
The positive vote, which is not binding, came about despite concerns from some panelists about the drug’s instructions and packaging, which caused confusion among some people in a company study. The manufacturer, Emergent Biosolutions, said it would review packaging and labeling to address those concerns. The FDA will make a final decision on the drug in the coming weeks.
Panelists urged the FDA to act quickly rather than wait for Emergent to conduct a follow-up study with the easier-to-understand label.
“There may be a much greater risk of product availability being delayed given the climate of this crisis and its devastating impact,” said Maria Coyle, an Ohio State University pharmacy professor who chaired the panel.
The prefilled nasal device, Narcan, is the leading version of the drug in the US, which is also available as an injection. If approved by the FDA, Narcan would be the first opioid treatment to make the regulatory switch to an over-the-counter drug.
The possible move represents the government’s latest effort to increase the use of a drug that has been an important tool in the fight against the US overdose epidemic that kills more than 100,000 people each year. The decades-old drug 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 for pharmacists to sell the drug to anyone who asks. But not all pharmacies carry it, and those that do have it must keep it behind the counter. Also, the stigma of opioids can discourage people from asking about the drug.
“We believe that over-the-counter naloxone can help break down these barriers,” said FDA’s Dr. Jody Green, who noted that the switch would allow the drug to be sold in vending machines, convenience stores and supermarkets.
Emergent presented the results of a 70-person study designed to show that people of different ages and backgrounds could quickly and correctly understand how to use the device in an emergency. About a third of the people in the study had low reading abilities, a group the FDA said should have been larger.
FDA staffers also warned that a number of participants had difficulty following the directions, in part because of how the multi-step instructions were laid out on two sides of the box, the FDA noted.
“Where’s step one?” one participant asked, according to interview transcripts from the study presented by the FDA.
Emergent said it plans to move all directions to a single panel and add icons, per the 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 the majority of adults and adolescents.
“Perfect should not be the enemy of good and the evidence we’ve seen today gives a clear indication that the drug can be used without a healthcare provider’s direction,” said Dr. Brian Bateman of Stanford University.
Government officials hope that moving naloxone beyond the pharmacy counter will boost sales, with potentially lower costs. Currently, the drug can cost $50 for a two-pack, if not covered by insurance.
Community advocates and organizations in favor of distributing the drug welcomed the possible approval of an over-the-counter version.
“It’s going to have a huge impact on how people view the medication,” said Sheila Vakharia, associate director of research and academic engagement at the Drug Policy Alliance. “It will help destigmatize it and let people know it’s safe and easy to use.”
But Maya Doe-Simkins, a Remedy Alliance/For The People co-director, worried that an over-the-counter version of Narcan could also lead to the perception that it is better than other forms of naloxone.
“We have some trepidation about how companies that have ‘over-the-counter’ products can misrepresent injectable products,” said Doe-Simkins, who has long advocated for an over-the-counter version.
Overdose death rates in the US began a steady rise in the 1990s, driven by painkillers. Waves of deaths followed, led by other opioids such as heroin and – most recently – illicit fentanyl. Nearly 107,000 Americans died of drug overdose in 2021, an all-time high, though recent data suggests deaths are declining.
Gaithersburg, Maryland-based Emergent Biosolutions makes most of its money from medical products purchased by the federal government for the Strategic National Stockpile, including anthrax drugs and vaccines.
In 2021, the company came to the public’s attention for its disastrous performance of COVID-19 vaccine production for Johnson & Johnson and AstraZeneca. Contamination problems at the company’s Baltimore plant eventually forced the drugmakers to throw away 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 division is supported by the Science and Educational Media Group of the Howard Hughes Medical Institute. The AP is solely responsible for all content.
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