Americans may soon no longer need a prescription to buy a life-saving nasal spray for people who overdose on opioids.
Emergent BioSolutions on Tuesday said the Food and Drug Administration has fast-tracked its application for an over-the-counter version of Narcan, a nasal-spray form of naloxone. Approved in 2015, Narcan and its somewhat less expensive generic competitors are widely used by first responders and laypeople to treat known or suspected opioid overdoses that kill tens of thousands of Americans in the U.S. each year.
The FDA's priority review means the agency could approve the spray to be sold in drugstores in late March of next year, the Gaithersburg, Maryland-based company stated in a news release.
"We are taking to this step to help address the rising and devastating number of opioid overdoses and fatalities happening across the country," Emergent CEO Robert Kramer said in a statement.
More than 105,000 Americans died of drug overdoses during the 12-month period ending in October 2021, with 66% of those deaths related to synthetic opioids like fentanyl, according to the Drug Enforcement Administration. The powerful painkiller is frequently mixed with other drugs like heroin.
The timing of Narcan's anticipated approval would put it ahead of rivals, including Pocket Naloxone, which have unveiled plans to commercialize an over-the-counter naloxone drug. The FDA had urged pharmaceutical firms to apply for approval of over-the-counter versions of naloxone amid an overdose crisis from synthetic opioids like fentanyl.
More than 150 people die every day from related overdoses, and last year more than 71,000 died from opioids containing fentanyl, according to the U.S. Centers for Disease Control and Prevention.
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