WASHINGTON (AP) — US health advisers said Wednesday that the overdose drug naloxone should be available over-the-counter to aid the nation’s response to the opioid crisis.
A panel of Food and Drug Administration experts unanimously switched after a day of presentations and discussions centered on whether untrained users could safely and effectively use nasal sprays in emergencies. voted in favor of.
The non-binding affirmative vote came despite concerns some panel members had about the instructions and packaging of the drug, causing confusion among some in the company survey. . Manufacturer Emergent Biosolutions said it will revise its packaging and labeling to address these concerns.The FDA is expected to 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 more descriptive label.
Maria Coyle, a professor of pharmacy at Ohio State University who chaired the committee, said, “Given the circumstances of this crisis and its devastating consequences, the risk of delays in obtaining products is probably much higher.
Narcan, a pre-filled nasal device, is the leading version of the drug in the United States and is also available as an injection. If approved by the FDA, Narcan will be the first opioid treatment that regulators will switch to over-the-counter.
The potential move represents the government’s latest effort to increase use of drugs, a key tool In the fight against an overdose epidemic in the United States that kills more than 100,000 people each year. A decades-old drug can counteract the effects of an opioid overdose in minutes.
Narcan is already available without a prescription in all 50 states, and state leaders have mandated pharmacists to sell the drug to anyone who needs it. However, not all pharmacies carry it, and those that do should keep it behind the counter. there is.
“We believe the non-prescription drug naloxone can help address these barriers,” said FDA’s Dr. Jody Green, who said the switch would allow the drug to be sold in vending machines, convenience stores and supermarkets. I pointed out that it would be
Emergent has announced the results of a 70-person study designed to show that people of different ages and backgrounds can quickly and accurately understand how to use their devices in an emergency. About a third of the people who participated in the study were poor readers, and the FDA says the group should have been larger.
FDA staff also warned that many participants had trouble following the instructions.
“Where’s step one?” asked one of the participants, according to an interview transcript of the study released by the FDA.
Emergent said it plans to move all orientations to one panel and add pictograms, per the FDA’s proposal.
Despite the flaws in the original packaging, a panel of 19 pain and medical education professionals expressed confidence that the product could be used effectively by most adults and adolescents.
Dr. Brian Bateman of Stanford University said:
Government officials hope moving naloxone off the pharmacy counter could increase sales and reduce costs. Two packs can cost $50.
Community advocates and organizations that support distribution of the drug have welcomed the possibility of approval for a commercial version.
Sheila Vakharia, Deputy Director of Research and Academic Affairs, Drug Policy Alliance, said: “It helps deprecate 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 commercial version of Narcan could lead to perceptions of it being superior to other forms of naloxone.
“We are concerned that companies selling over-the-counter medicines may be misrepresenting injectable products.”
Overdose mortality in the United States began rising steadily in the 1990s due to pain relievers.A wave of deaths followed, led by other opioids like heroin and, most recently, illegal fentanyl.Approximately 107,000 Americans. People will die from drug overdoses in 2021 at all-time high, but recent data suggests deaths may have plateaued.
Based in Gaithersburg, Maryland, Emergent Biosolutions derives most of its revenue from medical products purchased by the federal government for the Strategic National Stockpile, such as medicines and vaccines against anthrax.
In 2021, the company made headlines with its disastrous handling Contamination problems at Johnson & Johnson and AstraZeneca’s Baltimore plant producing COVID-19 vaccines ultimately forced drug companies to scrap hundreds of millions of dollars worth Vaccine dosage.
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This article was contributed by AP writer Jeff Malvihill of Cherry Hill, New Jersey.
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The Associated Press’ Health Sciences Division is supported by the Scientific and Educational Media Group at the Howard Hughes Medical Institute. AP is solely responsible for all content.
