Avadel Pharmaceuticals Inc. (NASDAQ: AVDL) stock gained by 6.96% at the last close whereas the AVDL stock price plunges by 14.41% in the after-hours trading session. Avadel Pharmaceuticals is a pharmaceutical firm dedicated to creating medications that improve people’s lives.
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The US Foods and Drug Administration (FDA) informed Avadel Pharmaceuticals that the evaluation of the New Drug Application (NDA) for FT218 is still underway and that no measures will be taken in October. The FDA has notified the business that no information requests have been received at this time and that a new target response date would be issued as soon as feasible.
FT218 is an experimental sodium oxybate formulation that uses Avadel’s patented drug delivery technology and is intended to be administered once at bedtime for the treatment of EDS or cataplexy in people with narcolepsy.
Avadel concluded the REST-ON study in March 2020, a major Phase 3 randomized, double-blind, placebo-controlled trial to investigate the effectiveness and tolerability of FT218 in individuals with narcolepsy. When FT218 was compared to placebo, it showed substantial and clinically relevant results in EDS, the clinician’s overall assessment of the patient’s functioning, and a drop in cataplexy episodes for all three dosages examined.
Greg Divis, Chief Executive Officer of Avadel commented,
They’ve responded to all the queries they’ve gotten so far, and they’re satisfied that the package they’ve filed meets all the FDA’s requirements. They have not been aware of any flaws in their application, and remain completely committed to working cooperatively with the FDA throughout its evaluation of their FT218 NDA. Once at bedtime, FT218 has the potential to significantly improve the quality of life for persons with narcolepsy, and they are committed to getting this essential medication available to patients as soon as possible.
The FDA approved Avadel’s FT218 NDA in February 2021 and set an October 15, 2021, planned action date. Positive results from the pivotal Phase 3 REST-ON trial, which was performed under a Special Protocol Assessment (SPA) agreement with the FDA, support the NDA application.
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