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Vanda Presents Data From Phase III Studies that Demonstrate Tasimelteon Restores Daily Cortisol Rhythm In Blind Patients With Non-24-Hour Disorder
Date:6/17/2013

response as measured by entrainment plus a score of greater than or equal to 3 on the Non-24 Clinical Response Scale (N24CRS).  Tasimelteon also demonstrated significant improvement versus placebo across a number of sleep and wake parameters including measures of total sleep time, nap duration, and timing of sleep, as well as in the Clinical Global Impression of Change (CGI-C), an overall global functioning scale.  In treated patients, daytime naps decreased by 46 minutes per day in the worst 25% of days in a cycle and nighttime sleep increased by 57 minutes per day during the worst 25% of nights in a cycle.

The RESET study demonstrated that continued treatment with 20mg of tasimelteon was required to maintain entrainment of melatonin and cortisol circadian rhythms in individuals with Non-24.  Patients treated with tasimelteon maintained their clinical benefits while patients who received placebo showed significant deterioration in measures of nighttime sleep, daytime naps and timing of sleep.  Furthermore, discontinuation of tasimelteon resulted in a rapid relapse to misaligned circadian rhythms, reinforcing the importance of chronic therapy. 

"These results clearly demonstrate that tasimelteon can entrain the circadian clock and is able to align melatonin and cortisol rhythms to the 24-hour social day," said Steven W. Lockley, Ph.D., Associate Professor of Medicine, Division of Sleep Medicine, Brigham and Women's Hospital, Harvard Medical School.

About Non-24-Hour Disorder 
Non-24 is a serious, rare, and chronic circadian rhythm disorder characterized by the inability to entrain (synchronize) the master body clock with the 24-hour day-night cycle.  Non-24 affects the majority of totally blind individuals, or between 65,000 and 95,000 people in the U.S.  Non-24 occurs almost entirely in individuals who lack the light sensitivity necessary to entrain the master bod
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SOURCE Vanda Pharmaceuticals Inc.
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11. Vanda Announces Positive Results in the Second Phase III Study (RESET) of Tasimelteon for the Treatment of Non-24-Hour Disorder
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