U.S. FDA to review Emergent's OTC opioid overdose drug on priority

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U.S. FDA to review Emergent's OTC opioid overdose drug on priority
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Contract drugmaker Emergent Biosolutions said on Tuesday its over-the-counter nasal spray as a treatment for suspected opioid overdose would be reviewed on a priority basis by the U.S. health regulator.

said on Tuesday its over-the-counter nasal spray as a treatment for suspected opioid overdose would be reviewed on a priority basis by the U.S. health regulator.

The agency will make its decision by March 29 and its priority review status puts Narcan on track to become the first naloxone-based drug to be sold over the counter, Benchmark analyst Robert Wasserman said. There are legal barriers limiting access to naloxone in some states, and even in others the drug is not always available to those most at risk of an overdose.

Government data estimates that there were more than 100,000 drug-related overdose deaths in the country during 2021, a near 15% increase from the year earlier.

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