Avadel Pharmaceuticals Announces Interim Data for FT218 as Once-Nightly Dose

FT218 is an investigational formulation of sodium oxybate that is designed to be taken once at bedtime for the treatment of excessive daytime sleepiness for individuals with narcolepsy.

Avadel Pharmaceuticals announced the presentation of interim data from the ongoing RESTORE study, which is an open-label extension/switch study of FT218, at the American Academy of Neurology Annual Meeting being held virtually from April 24 to April 26, 2022.

FT218 is an investigational formulation of sodium oxybate that is designed to be taken once at bedtime for the treatment of excessive daytime sleepiness or cataplexy in individuals with narcolepsy.

The presentation highlights results from a questionnaire that assessed patient preference for the once-nightly dosing regimen vs a twice-nightly dosing regimen. An additional questionnaire assessed experiences with the second nightly dose in individuals 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,” Asim Roy, MD, medical director of the Ohio Sleep Medicine Institute, said in a statement.

“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,” he said.

The cut-off date for interim data was September 7, 2021, and included 35 individuals who switched from twice-nightly oxybates to a once-at-bedtime dose of FT218. The individuals completed the patient preference questionnaires 3 months after switching.

The results showed that approximately 94.3% of individuals preferred the once-nightly dose to the twice-nightly dosing regimen.

As of the data cutoff, 60 individuals who switched from the twice-nightly oxybate to FT218 also completed a nocturnal adverse event questionnaire prior to switching regimens, which assessed their experiences with the second nightly sodium oxybate dose.

Approximately 63% of individuals unintentionally missed their second dose of oxybate within the preceding 3 months. Of these individuals, approximately 84% indicated that their narcolepsy symptoms were worse the next day.

Additionally, 40% of individuals reported that they had taken their second dose more than 4 hours after the first dose, and 42% of those individuals reported feeling somewhat quite a bit or extremely groggy or unsteady the next morning.

Furthermore, approximately 73% of individuals who were taking a second nighttime dose characterized it as somewhat or quite a bit or extremely inconvenient, with 90% reporting that they arose from bed after the second dose. Three of those individuals reported associated falls, with 2 reporting injuries.

Additionally, anxiety and the need for someone else to wake them was reported by 20% and 23% of individuals, respectively.

“These interim results from the ongoing RESTORE study highlight the preference for the once-at-bedtime versus twice nightly dosing regimen among individuals who have switched from the twice-nightly formulation,” Douglas Williamson, MD, chief medical officer of Avadel, said in the statement. “By eliminating the need for a second dose, FT218 has the potential to ease the burden facing sodium oxybate-eligible narcolepsy patients, if approved.”.

Reference

Avadel Pharmaceuticals announces interim data from the open-label RESTORE study at the 2022 American Academy of Neurology Annual Meeting. Avadel. News release. April 25, 2022. Accessed April 25, 2022. https://investors.avadel.com/news-releases/news-release-details/avadel-pharmaceuticals-announces-interim-data-open-label-restore