Avadel files US application for its lead drug

 

• Avadel Pharmaceuticals (NASDAQ:AVDL) rises 6% in premarket after submitting its marketing application to the FDA seeking approval for its lead candidate FT218, once-nightly formulation of sodium oxybate using Micropump technology for extended-release oral suspension, for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.
• In April this year, the company announced positive results from a Phase 3 trial. The study met all three co-primary endpoints at all three doses tested demonstrating statistically significant improvements compared to placebo.
• https://seekingalpha.com/news/3644857-avadel-files-us-application-for-lead-drug