Non-prescription Narcan from Gaithersburg’s Emergent BioSolutions gets FDA fast-track

Gaithersburg, Maryland-based Emergent BioSolutions has received fast-track review status for making Narcan available without a prescription.

Emergent BioSolutions is the maker of Narcan, the nasal spray version of opioid overdose antidote naloxone.

The FDA has accepted for review Emergent’s supplemental new drug application for Narcan as an over-the-counter emergency treatment for known or suspected opioid overdose. The priority review status means the FDA will issue its decision on March 29, 2023.

All versions of naloxone, including an injectable version, currently require a prescription, though access laws allow paramedics and other first responders to carry it. All 50 states have standing orders that also allow pharmacies to dispense the drug without a doctor’s prescription to other authorized individuals.

Deaths related to synthetic opioids, namely fentanyl, increased 60% from 2019 to 2020 in the U.S., according to the Centers for Disease Control and Prevention. In 2021 alone, more than 71,000 people in the U.S. died from opioids containing fentanyl.

“As a leader in the fight to help combat the opioid epidemic, Emergent is committed to increasing access and awareness of naloxone, and we are taking this step to help address the rising and devastating number of opioid overdoes and fatalities happing across the country,” said Robert Kramer, president and CEO of Emergent BioSolutions.

Narcan was approved in 2015.

Emergent gained 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 and first responders, public health clinics, fire departments and police departments.

Emergent’s Narcan sales in the third quarter totaled $45.4 million, lower than a year earlier following the approval of a generic version licensed to pharmaceutical company Sandoz.

Emergent expects Narcan sales to total $350 million to $365 million for all of 2022.

Jeff Clabaugh

Jeff Clabaugh has spent 20 years covering the Washington region's economy and financial markets for WTOP as part of a partnership with the Washington Business Journal, and officially joined the WTOP newsroom staff in January 2016.

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