According to a report in FIERCE Biotech, Avadel Pharmaceuticals’ shares have gone down 48% to $1.72, compared to a prior close of $3.38. The drop came after approval for Avadel Pharmaceuticals’ narcolepsy drug was set back to 2023 due to a patent issue flagged by the FDA.
“The company revealed the delay in a regulatory filing,” writes reporter Annalee Armstrong. “According to the document, the application for FT218 is on hold while Avadel adds a certification to its Risk Evaluation and Mitigation Strategies patent, which the FDA determined was inappropriate.”
FIERCE Biotech confirms that this is the latest delay for Avadel’s efforts to get FT218 approved. “The therapy was one of the medicines snared up in the FDA’s inspection delays last year driven by outbreaks of COVID-19 that prevented the agency from completing manufacturing facility inspections,” adds Armstrong. “The original decision date was October 15, 2021, after Avadel submitted the application in February 2021.”