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Vanda Pharmaceuticals Initiates Phase III Clinical Study Aimed at Resetting the Body Clock
Date:8/26/2010

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Non-24-Hour Sleep Wake Disorder (N24HSWD)

N24HSWD is an orphan indication affecting approximately 65,000 to 95,000 in the U.S. and 140,000 in Europe.  N24HSWD occurs when individuals, primarily blind with no light perception, are unable to synchronize their endogenous circadian pacemaker to the 24-hour light/dark cycle.  Without light as a synchronizer, and because the period of the internal clock is typically a little longer than 24 hours, individuals with N24HSWD experience their sleep/wake cycles drifting later and later each day.  Individuals with N24HSWD have abnormal night sleep patterns, accompanied by difficulty staying awake during the day.  N24HSWD leads to significant impairment, with chronic effects impacting the social and occupational functioning of these individuals.

The ultimate treatment goal for individuals with N24HSWD is to lock or synchronize their circadian rhythms into an appropriate phase relationship with the 24-hour day so that they will have increased sleepiness during the night and increased wakefulness during the daytime.

Tasimelteon

Tasimelteon is a circadian regulator which binds to two high affinity melatonin receptors, Mel1a (MT1R) and Mel1b (MT2R).  These receptors are found in high density in the suprachiasmatic nucleus of the brain (SCN) which is responsible for synchronizing our sleep/wake cycle.  Tasimelteon has been shown to improve sleep parameters in prior clinical studies, which simulated a desynchronization of the circadian clock.  Tasimelteon has so far been studied in more than 900 individuals and has shown a good tolerability profile.  

About Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders. For more on Vanda, please visit

SOURCE Vanda Pharmaceuticals Inc.
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