OTC approval for Narcan could be a boon for a Gaithersburg company

Investors ran up stock in Gaithersburg, Maryland-based Emergent BioSolutions Wednesday, after the U.S. Food and Drug Administration approved opioid overdose treatment Narcan for over-the-counter sales.

While it is unclear how much demand there will be for the nasal spray version of naloxone, and no pricing has been set, Emergent is the maker of Narcan, and demand could be a boon for the company’s revenue.

In December, the FDA gave Emergent fast-track review status for making Narcan widely available to the public without a prescription.

Emergent gained rights to the drug as part of its 2018 acquisition of Adapt Pharma. Since then, it 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 Narcan is now currently the only naloxone nasal spray approved by the FDA for over-the-counter sales.

The approval of Emergent BioSolutions Narcan requires a change in labeling for currently-approved generic versions of naloxone nasal spray products that rely on Narcan as their reference listed in the drug product.

Generic manufacturers are also required to submit a supplement to their applications to effectively switch their products to OTC status.

All versions of naloxone, including an injectable version, until now have required 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.

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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