A Food and Drug Administration (FDA) panel voted unanimously Wednesday to recommend that the overdose-reversal drug naloxone, which is commonly used through a prefilled nasal device known as Narcan, should be made available over the counter to help combat the opioid epidemic.
Experts on the panel cast a unanimous but non-binding vote in favor of making the nasal spray available over the counter after a full day of presentations. Some of the panelists raised concerns about the drug's instructions and packaging, which were found to cause confusion among some people surveyed in a company study. The manufacturer, Emergent Biosolutions, said it would revise the labeling and packaging to address those concerns.
The FDA is expected to make a final decision in the coming weeks. Panelists urged the FDA to move swiftly to issue final approval for the over-the-counter drug rather than waiting for Emergent to conduct a follow-up study with an easier-to-understand label.
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"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 the FDA approves, Narcan would be the first opioid treatment to make the regulatory switch to a non-prescription drug. The drug, which has been around for decades, can counter the effects of an opioid overdose in minutes. This comes amid an overdose epidemic that claimed the lives of nearly 107,000 Americans in 2021, an all-time high.
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Narcan is already available without a prescription in all 50 states, and pharmacists have been instructed by state officials to sell the drug to anyone who requests it. However, not all pharmacies carry it and those that do are required to keep it behind the counter. There are also concerns that the stigma of opioids may discourage some people from asking for the drug.
"We believe that nonprescription naloxone may help address these barriers," said the FDA’s Dr. Jody Green, noting that the switch would allow the drug to be sold in vending machines, convenience stores and supermarkets.
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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.
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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.
The Associated Press contributed to this report.
