- Once-at-bedtime FT218 demonstrated clinically meaningful improvement in assessments of disrupted nighttime sleep compared to placebo in adults with narcolepsy
- New data bolster positive primary endpoint data from the completed Phase 3 REST-ON trial and indicate that FT218 positively impacts both daytime and nighttime symptoms of narcolepsy
Approximately 65% of people with narcolepsy are estimated to have nocturnal sleep disturbances.1 While people living with narcolepsy may be able to fall asleep easily, their sleep tends to include frequent arousals and stage shifts and is often not refreshing. Most treatments for narcolepsy are taken in the morning to combat EDS; only oxybate treatments are taken at bedtime, with current immediate-release formulations taken twice nightly. To evaluate the potential for improvement on sleep architecture with a single bedtime dose of FT218, secondary endpoints from the double-blind, placebo-controlled REST-ON trial were assessed, including polysomnographic measures of sleep stage shifts and nocturnal arousals. In addition, patient-reported assessments of sleep quality and refreshing nature of sleep, as measured on a visual analog scale, were analyzed. Highlights from the analyses follow:
- At all doses evaluated (6, 7.5 and 9 g), once-at-bedtime FT218 demonstrated a statistically significant decrease in the number of transitions from stages N1, N2, N3, and rapid eye movement (REM) sleep to wake and from N2, N3, and REM sleep to N1 (P<0.001 at all doses) and number of nocturnal arousals (P<0.05 at 6 g; P<0.001 at 7.5 and 9 g) compared to placebo.
- Sleep quality and refreshing nature of sleep were significantly improved with all evaluated doses compared to placebo (P<0.001).
- A post-hoc analysis showed that significant improvements in DNS were observed regardless of concomitant stimulant use.
- Additional post-hoc data further supported improvements in sleep architecture with increases in N3, or slow wave sleep and increased REM latency.
“DNS is a frequent, bothersome, but often minimized symptom of narcolepsy,” said
The primary safety and efficacy results from REST-ON were published in
“While the treatment of narcolepsy often focuses on alleviating daytime symptoms, such as EDS, these results highlight the importance of a potential treatment option that also addresses nighttime symptoms,” said
About Narcolepsy
Narcolepsy is a chronic neurological condition that impairs the brain's ability to regulate the sleep-wake cycle. The condition affects approximately one in 2,000 people in
About FT218
FT218 is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of EDS or cataplexy in adults with narcolepsy.
In
In
Avadel is currently evaluating the long-term safety and tolerability of FT218 in the open-label RESTORE clinical study. For more information, visit: www.restore-narcolepsy-study.com.
About Avadel Pharmaceuticals plc
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, our expectations of the therapeutic benefits and tolerability of FT218, if approved. 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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Investor Contact:
Stern Investor Relations, Inc.
Courtney.Turiano@sternir.com
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Real Chemistry
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References:
- Basseti et al. European guideline and expert statements on the management of narcolepsy in adults and children. Eur J Neurol. 2021 Sep;28(9):2815-2830.
Source:
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