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FDA Accepts Tasimelteon New Drug Application For Priority Review In The Treatment Of Non-24-Hour Disorder In The Totally Blind
Date:7/29/2013

cessary to entrain the master body clock in the brain with the 24-hour day-night cycle.  Most people have a master body clock that naturally runs longer than 24-hours and light is the primary environmental cue that resets it to 24 hours each day.  Individuals with Non-24 have a master body clock that is not reset, and continually delays, resulting in prolonged periods of misalignment between their circadian rhythms and the 24-hour day-night cycle, including the timing of melatonin and cortisol secretion.  As a result of this misalignment, Non-24 is associated with significant disruption of the sleep-wake cycle and impairments in social and occupational functioning, and marked subjective distress.  Currently there is no approved treatment for Non-24.  For more information on Non-24, please visit www.Non-24.com.

About Tasimelteon
Tasimelteon is a circadian regulator in development for the treatment of Non-24.  Tasimelteon is a dual melatonin receptor agonist (DMRA) with selective agonist activity at the MT1 and MT2 receptors.  Tasimelteon aims to reset the master body clock in the suprachiasmatic nucleus (SCN), resulting in the entrainment of the body's melatonin and cortisol rhythms to align to the 24-hour day-night cycle.  The patent claiming tasimelteon as a new chemical entity extends through December 2022, assuming a 5-year extension to be granted under the Hatch-Waxman Act.  Tasimelteon has been granted orphan drug designation for the treatment of Non-24 from both the U.S. and the European Union.  Tasimelteon has not been approved by the FDA or any other regulatory authority.

About Tasimelteon NDA
Summary of Efficacy
The efficacy of tasimelteon as a circadian regulator of the master body clock in the treatment of Non-24 was studied in two randomized, double-masked, placebo-controlled, multicenter, parallel-group trials, SET (Safety and E
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SOURCE Vanda Pharmaceuticals Inc.
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4. Vanda Presents Data From Phase III Studies that Demonstrate Tasimelteon Restores Daily Cortisol Rhythm In Blind Patients With Non-24-Hour Disorder
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