Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy.

Authors:
Kushida CA; Shapiro CM; Roth T; Thorpy MJ; Corser BC and 6 more

Journal:
Sleep

Publication Year: 2022

DOI:
10.1093/sleep/zsab200

PMCID:
PMC9189976

PMID:
34358324

Journal Information

Full Title: Sleep

Abbreviation: Sleep

Country: Unknown

Publisher: Unknown

Language: N/A

Publication Details

Subject Category: Psychophysiology

Available in Europe PMC: Yes

Available in PMC: Yes

PDF Available: No

Transparency Score
4/6
66.7% Transparent
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Evidence found in paper:

"Financial Disclosure Statement DS is an employee of Avadel Pharmaceuticals. JD is a consultant to, stockholder and former employee of Avadel Pharmaceuticals. Nonfinancial Disclosure Statement CAK is a consultant of Avadel Pharmaceuticals and XW Pharma. CMS is a consultant and has served on speakers bureaus for Avadel Pharmaceuticals and Jazz Pharmaceuticals. TR is a consultant for Jazz Pharmaceuticals, Takeda Pharmaceutical Co., Orexo, Avadel Pharmaceuticals, Eisai, Merck & Co., and Idorsia. MJT has served as a consultant or on advisory boards for Axsome Therapeutics, Balance Therapeutics, Eisai, Avadel Pharmaceuticals, Harmony Biosciences, Jazz Pharmaceuticals, NLS Pharmaceuticals, Suven Life Sciences Ltd., and Takeda Pharmaceutical Co. BCC is a member of the speakers’ bureau and has received honoraria from Jazz Pharmaceuticals, Eisai, and Harmony Biosciences. He is an advisor and has received consulting fees and honoraria from Avadel Pharmaceuticals. He is a member of the speakers’ bureau for Merck & Co. Inc. AOA is a consultant for Avadel Pharmaceuticals. RR received research grant funding by Avadel Pharmaceuticals to conduct the current study. He has also received research grant support from Jazz Pharmaceuticals, Eisai, Merck & Co., Apnimed, Inc., Idorsia, Biohaven, and Suven Life Sciences Ltd. He has participated in advisory boards for Jazz Pharmaceuticals, Eisai, and Harmony Biosciences. AR has received grant/research support for Jazz Pharmaceuticals, Suven, Inspire, Nyxoah, LivaNova, and Avadel Pharmaceuticals; is a consultant for Jazz Pharmaceuticals, Suven, Inspire, and Avadel Pharmaceuticals; and has served on speakers bureaus for Jazz Pharmaceuticals and Eisai. YD has served as a consultant or on advisory boards for Avadel Pharmaceuticals, Jazz Pharmaceuticals, UCB, Takeda Pharmaceutical Co., Theranexus, Harmony Biosciences, Bioprojet Pharma, and Idorsia."

Evidence found in paper:

"Funding This study was funded by Avadel Ireland. Avadel was involved in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication."

Evidence found in paper:

"Clinical Trial Registration ClinicalTrials.gov: NCT02720744, https://clinicaltrials.gov/ct2/show/NCT02720744."

Open Access
Paper is freely available to read
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Last Updated: Aug 05, 2025