Thursday, February 16, 2023

Gaithersburg's Emergent BioSolutions gets thumbs-up from FDA committees on OTC use of NARCAN


Emergent BioSolutions
 and its stockholders have received promising news from the U.S. Food and Drug Administration. Two FDA committees voted unanimously to approve over-the-counter use of the company's NARCAN nasal-spray, which can be administered to patients suffering from an opioid overdose. If the FDA gives final approval, NARCAN will be the first 4 mg naloxone nasal spray to become available to consumers as an over-the-counter product in the United States. 

"This favorable recommendation marks another important step forward to broaden access to NARCAN Nasal Spray for those who may be at risk of an opioid overdose,” Paul Williams, SVP and Products Business Head, Emergent BioSolutions, said in a statement yesterday. “Today’s vote reaffirms our confidence in the safe and effective use of NARCAN in the community setting. We want to thank the participants in the open public hearing who shared their insights and personal experiences informing the need to make NARCAN more readily available over the counter.” With the fentanyl crisis and pandemic alone, what a few years it has been for Montgomery County's biotech sector, the lone bright spot in a stagnant county economy.

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