An Open Label Study of FT218 in Subjects With Narcolepsy

Summary

An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy

Timeline

Start

2020-06-12

Primary completion

2023-12-22

Completion

2024-11-18

Publications

• Roy A, Stern T, Harsh J, Corser BC, Santamaria A, Abaluck B, Ibrahim S, Lancaster K, Gudeman J. Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates: a plain language summary of publication. Expert Rev Neurother. 2026 Jul;26(7):701-711. doi: 10.1080/14737175.2026.2668473. Epub 2026 May 20.
• Roy A, Stern T, Harsh J, Hudson JD, Ajayi AO, Corser BC, Mignot E, Santamaria A, Morse AM, Abaluck B, Ibrahim S, Schweitzer PK, Lancaster K, Dubow J, Gudeman J. RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates. Sleep Med X. 2024 Aug 15;8:100122. doi: 10.1016/j.sleepx.2024.100122. eCollection 2024 Dec 15.

Drugs

Indications