Benzinga | Mar 1, 2021 12:11PM EST

Avadel's US Application In Sleep Disorder Accepted For Review

The FDA has accepted Avadel Pharmaceuticals Plc's (NASDAQ: AVDL) marketing application seeking approval for FT218 for review. FT218 is a formulation to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.

* The FDA has assigned the target action date of October 15.

* Narcolepsy is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep.

* FT218 is a once-nightly formulation of sodium oxybate that includes Avadel's MicroPump controlled-release technology.

* The Company plans to present data from the Phase 3 REST-ON study for the three primary endpoints and several secondary endpoints and post-hoc analyses at upcoming conferences in the first half of 2021.

* Price Action: AVDL shares are up 1.7% at $8.18 in market trading hours on the last check Monday.