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Avadel Pharmaceuticals Announces First Patient Dosed in Open-Label Extension/Switch Study of Investigational Once-Nightly FT218 as a Potential Treatment for Excessive Daytime Sleepiness and Cataplexy in Patients with Narcolepsy
- Clinical study to enroll 250 patients from sites that participated in the REST-ON study
- Study to examine the long-term safety and maintenance of efficacy in patients, and evaluate dosing and preference for patients switching from twice-nightly sodium oxybate to once-nightly FT218
“Narcolepsy is a rare neurological sleep disorder with limited treatment options. We were encouraged by the positive Phase 3 data from the REST-ON study that evaluated FT218 as a potential treatment for excessive daytime sleepiness and cataplexy in patients with narcolepsy, so we are enrolling our patients in the open-label extension/switch study. We are pleased to be the first site participating in the study advancing clinical research on narcolepsy to potentially provide our patients more treatment options,” said Akinyemi Ajayi, M.D., principal investigator and Sleep Disorder Specialist.
The OLE/switch study will examine the long-term safety and maintenance of efficacy of FT218 in patients with narcolepsy who participated in the REST-ON study, as well as dosing and preference data for patients switching from twice-nightly sodium oxybate to once-nightly FT218 regardless if they participated in REST-ON or not. The study will enroll about 250 patients at most of the North American clinical trial sites that participated in the REST-ON study.
FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The Company recently completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the
Cautionary Disclosure Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to i) the potential benefits of FT218 including the long-term safety and maintenance of efficacy of FT218, and ii) the anticipated enrollment for the OLE/switch study. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions, and the negatives thereof (if applicable).
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Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.
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Source: Avadel Pharmaceuticals plc