AVDL - Avadel files US application for its lead drug
Avadel Pharmaceuticals (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.
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Avadel files US application for its lead drug