A recent presentation focusing on Avadel Pharmaceuticals plc’s once-nightly sodium oxybate drug candidate for narcolepsy (FT218) at the virtual version of the 2022 American Academy of Neurology Annual Meeting highlights results from two narcolepsy patient questionnaires. One questionnaire assessed patient preference for the once-nightly versus twice-nightly dosing regimen and another assessed experiences with the second nightly dose in patients who switched from twice-nightly oxybates to FT218.
“Twice-nightly oxybates for narcolepsy require a challenging dosing regimen that disrupts nighttime sleep. The results from the nocturnal adverse event questionnaire illustrate the burden that the second dose places on some patients, who already struggle with getting a full night of refreshing sleep,” says Asim Roy, MD, presenting author and Medical Director of the Ohio Sleep Medicine Institute, in a release. “In my experience with patients in my practice, a once-at-bedtime option like FT218 would ease this burden and has the potential to be a major advance for the entire narcolepsy community.”
At an interim data cutoff date of September 7, 2021, 35 participants who switched from twice-nightly oxybates to once-at-bedtime FT218 completed patient preference questionnaires three months after switching, with responses indicating that 94.3% (33/35 participants) preferred the once-nightly versus twice-nightly dosing regimen. As of the data cutoff, 60 participants who switched from twice-nightly oxybates to FT218 also completed a nocturnal adverse event questionnaire prior to switching to assess their experiences with the second nightly sodium oxybate dose.
Results from the questionnaire follow:
- Out of 60 participants, 38 (63%) 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.
- Out of 60 participants, 24 (40%) 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. Anxiety and the need for someone else to wake them were reported by 20% and 23% of participants, respectively.
“These interim results from the ongoing RESTORE study highlight the preference for the once-at-bedtime versus twice-nightly dosing regimen among people who have switched from the twice-nightly formulation,” says Douglas Williamson, MD, chief medical officer of Avadel, in a release. “Further, they provide an insight into the challenges that patients face with a second, middle-of-the-night dose; challenges which may have been underappreciated due to the lack of other oxybate options. By eliminating the need for a second dose, FT218 has the potential to ease the burden facing sodium oxybate-eligible narcolepsy patients, if approved.”
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 or cataplexy in adults with narcolepsy. A marketing application for FT218 is currently under review by the FDA.