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Avadel Pharmaceuticals Announces Submission of New Drug Application for FT218 to the FDA

December 17th, 2020

Avadel Pharmaceuticals plc announced the submission of its New Drug Application to the US Food and Drug Administration (FDA) for FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.

In March 2020, Avadel completed their REST-ON study, a double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. FT218 has been granted Orphan Drug Designation from the FDA for the treatment of narcolepsy. 

Read the full statement from Avadel here

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Date Created: December 17th, 2020
Last Updated: December 21st, 2023