'As our NDA for FT218 continues in late-stage review, we stand at a pivotal moment for the company and our stakeholders, ready and excited to bring this important medicine to people living with narcolepsy. As we have communicated in the past, based on our interactions with the FDA to date, we continue to believe in the full approvability of FT218, and are devoted to continuing to work with the FDA to complete the review of our NDA,' said
First Quarter and Recent Company Highlights
Avadel continues to have interactions with the
Launch readiness activities progress on-track to support the potential commercialization of FT218, which, if approved, would be the first and only once-at-bedtime option for managing excessive daytime sleepiness (EDS) and cataplexy in narcolepsy.
Presented interim data from the open-label RESTORE study at the 2022
At an interim data cutoff date of
As of the data cutoff, 60 participants who switched from twice-nightly oxybates to once-at-bedtime FT218 also completed a nocturnal adverse event questionnaire prior to switching to assess their experiences with the second nightly sodium oxybate dose. Results included:
38 (63%) participants unintentionally missed their second twice-nightly oxybate dose within the preceding three months. Of these participants, 84% indicated that their narcolepsy symptoms were worse the next day.
24 (40%) participants reported that they had taken their second dose more than four hours after the first dose. Of these participants, 42% (10/24) reported feeling somewhat, quite a bit or extremely groggy or unsteady the next morning.
For 73% (44/60) of participants, taking a second nighttime dose was characterized as somewhat, quite a bit or extremely inconvenient, with 54 (90%) reporting that they arose from bed after the second dose, three reporting associated falls and two reporting injuries. In addition, anxiety or concern related to taking the second dose and the need for someone else to wake them were reported by 20% and 23% of participants, respectively.
Presented multiple posters at World Sleep 2022, including new data that contributes to the growing body of evidence to support the potential benefit of FT218 for people living with narcolepsy.
Published positive secondary endpoint data from the REST-ON trial of FT218 in CNS Drugs.
At all doses evaluated (6g, 7.5g and 9g), FT218 demonstrated a statistically significant decrease in the number of transitions from stages N1, N2, N3, and rapid eye movement (REM) sleep to wake. Sleep quality and refreshing nature of sleep were significantly improved with all evaluated doses compared to placebo.
Completed the exchange and an eight-month maturity extension on
About FT218
FT218 is an investigational formulation of sodium oxybate leveraging our 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
In
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