Avadel Pharmaceuticals plc (Nasdaq: AVDL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. The FDA assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2021.
“The FDA’s acceptance of our NDA for once-nightly FT218 and assignment of a PDUFA target action date of October 15th represents another important milestone on the path towards receiving approval. We are confident in our regulatory filing strategy and we look forward to working with the Agency in our pursuit of bringing this important treatment to patients,” said Greg Divis, Chief Executive Officer of Avadel. “If approved, FT218 will be the first and only once-nightly oxybate medication, a significant advancement to the twice-nightly regimen that has been required for nearly 20 years.”
“It’s important to remember that FT218 was granted Orphan Drug Designation by the FDA based on the plausible hypothesis that it may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the Agency for the same indication. If the FDA approves FT218 and grants Orphan Drug Exclusivity, then we would be awarded a seven-year period of market exclusivity in the U.S.,” concluded Mr. Divis.
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. The Company plans on presenting data from the study for the three primary endpoints, as well as a number of secondary endpoints and post-hoc analyses at upcoming conferences in the first half of 2021.
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