U.S. FDA grants priority review for Emergent’s OTC opioid drug By Reuters

(Reuters) -Contract drugmaker Emergent Biosolutions (NYSE:) said on Tuesday its over-the-counter nasal spray as a treatment for suspected opioid overdose would be reviewed on a priority basis by the U.S. health regulator.

Emergent is seeking the U.S. Food and Drug Administration’s approval for a prescription-free sale of its nasal spray, Narcan, which is already cleared for the treatment of opioid overdose in the country.

If approved following the agency’s priority review by March 29, the spray could become the first naloxone-based drug to be sold over the counter.

If approved, Narcan is likely to face competition from generic versions of the drug which will pressure margins for Emergent, Cowen analyst Boris Peaker said in a note.

Rival Opiant Pharmaceuticals (NASDAQ:) Inc’s drug nalmafene, which is also under review in the United States, could pose an additional risk to Narcan sales as it provides better protection against opioid overdose, Peaker added.

Emergent’s announcement comes a few weeks after the agency said naloxone might be safe and effective for over-the-counter use in some forms, potentially paving the way for its use federally. 

There are legal barriers limiting access to naloxone in some states, and even in others the drug is not always available to those most at risk of an overdose.

The worsening opioid crisis has prompted U.S. President Joe Biden’s administration to develop newer strategies, including the use of naloxone.

Government data estimates that there were more than 100,000 drug-related overdose deaths in the country during 2021, a near 15% increase from the year earlier.

The Maryland-based company said its application to the health regulator includes data that supports safe and effective use of Narcan based on usability and more than five years of post-marketing studies.

Earlier in the day, the company’s shares rose nearly 3% before reversing course to trade lower nearly 2%.