Gaithersburg’s Emergent BioSolutions Non-Prescription Narcan Obtains FDA Fast Track

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

Emergent BioSolutions is the maker of Narcan, the nasal spray version of the 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 a known or suspected opioid overdose. 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, although access laws allow paramedics and other first responders to carry it.

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

“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 action to help combat the growing number and devastating opioid abuse and deaths occurring across the country,” said Robert Kramer, president and CEO of Emergent BioSolutions.

Narcan was approved in 2015.

Emergent secured the rights to the drug through its acquisition of Adapt Pharma in 2018. Since then, Emergent has distributed millions of prescription Narcan devices to national, state, and local health departments and first responders, public health clinics, firefighters and police departments.

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

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

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