FDA Panel to Review Emergent’s Over-the-Counter Opioid Overdose Drug

Signage outside of the Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. Andrew Kelly/Reuters

The U.S. health regulator said on Tuesday its advisory panel will meet on Feb. 15 to review Emergent Biosolutions Inc.’s over-the-counter (OTC) nasal spray to treat suspected opioid overdoses.

Emergent is seeking the Food and Drug Administration’s (FDA) approval for the prescription-free sale of Narcan, its nasal spray form of the drug naloxone. Narcan is already cleared for the treatment of opioid overdose in the country.