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Avadel : FDA's Review Of NDA Of FT218 On Narcolepsy Still Ongoing, No Action Taken In October

The U.S. Food and Drug Administration notified Avadel Pharmaceuticals plc (AVDL) that the review of the New Drug Application (NDA) for FT218 is still ongoing, and action will likely not be taken in October.

AVDL closed Friday regular trading at $9.99 up $0.65 or 6.96%. But in the after-hours trade, the stock dropped $1.43 or 14.31%.

The FDA informed the company that there are no information requests at this time and a new target action date will be provided as soon as possible.

The company said it has not been informed of any deficiencies in its application and remain fully committed to work closely with the FDA for the duration of its review of our NDA for FT218.

FT218 is an investigational formulation of sodium oxybate leveraging Avadel's proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

In February 2021, the FDA accepted Avadel's NDA for FT218 and assigned a target action date of October 15, 2021. The NDA submission is supported by positive data from the pivotal Phase 3 REST-ON study, which was completed under a Special Protocol Assessment (SPA) agreement with the FDA.

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