A panel of U.S. Food and Drug Administration (FDA) experts has unanimously voted in favor of making the overdose-reversing drug naloxone available over the counter.
The vote, which is not binding, took place after a full day of presentations and discussions, where concerns were raised about the drug’s instructions and packaging, which caused confusion among some users.
The manufacturer, Emergent Biosolutions, has pledged to revise the packaging and labeling to address these concerns. Naloxone, which can counteract the effects of an opioid overdose in minutes, is already available without a prescription in all 50 states.
If approved, Narcan, the leading version of the drug in the U.S., would be the first opioid treatment to make the regulatory switch to a non-prescription drug.
The potential move represents the latest government effort to increase the use of medication that has been a key tool in the battle against the U.S. overdose epidemic that kills more than 100,000 people annually. However, the FDA will make a final decision on the drug in the coming weeks.
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