Health
Emergent BioSolutions of Gaithersburg’s non-prescription drug Narcan receives FDA priority review
Emergent BioSolutions, based in Gaithersburg, Maryland, has been granted priority review status to make Narcan available without a prescription.
Emergent BioSolutions, based in Gaithersburg, Maryland, has been granted priority review status to make Narcan available without a prescription.
Emergent BioSolutions is the maker of Narcan, a nasal spray version of the opioid overdose antidote naloxone.
The FDA has accepted for review Emergent’s additional New Drug Application for Narcan as an over-the-counter emergency treatment for known or suspected opioid overdoses. Priority Review status means the FDA will make a decision on March 29, 2023.
All versions of naloxone, including the injectable version, currently require a prescription, but access laws allow paramedics and other first responders to carry it.
According to the Centers for Disease Control and Prevention, deaths associated with the synthetic opioid, or fentanyl, increased 60% in the United States from 2019 to 2020. In 2021 alone, more than 71,000 people in the United States died from opioids, including fentanyl.
“As a leader in the fight to help combat the opioid epidemic, Emergent is committed to increasing access and awareness of naloxone, leading to rising deaths and devastating opioid overdoses across the country. We are taking this step to address the growing numbers,” said Robert Kramer, president and CEO of Emergent BioSolutions.
Narkan was approved in 2015.
Emergent acquired rights to the drug as part of its 2018 acquisition of Adapt Pharma. Since then, Emergent has distributed millions of prescription Narcan devices to national, state and local health departments, first responders, public health clinics, fire departments and police departments.
Emergent’s third quarter sales of Narcan totaled $45.4 million, down from the year-ago quarter following approval of a generic version licensed to pharmaceutical company Sandoz.
Emergent expects total Narcan sales to be between $350 million and $365 million in 2022 as a whole.
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