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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

fficacy of Tasimelteon) and RESET (Randomized withdrawal Study of the Efficacy and safety of Tasimelteon).  In the SET study, tasimelteon achieved the primary endpoints of entrainment (synchronizing) of the melatonin rhythm and clinical response as measured by entrainment plus an improvement on the Non-24 Clinical Response Scale.  Tasimelteon also demonstrated statistically significant improvement in measures of nighttime sleep, daytime nap duration, timing of sleep, and overall global functioning scale.  In patients treated with tasimelteon, 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 patients who continued treatment with 20 mg of tasimelteon maintained entrainment of melatonin and cortisol circadian rhythms at statistically significantly greater percentages than patients receiving placebo.  Patients treated with tasimelteon also maintained their clinical benefits while patients who received placebo showed significant deterioration in measures of nighttime sleep, daytime naps and timing of sleep. 

Summary of Safety  
The Integrated Summary of Safety (ISS) for the tasimelteon development program included data from over 1,300 subjects treated with tasimelteon including 111 subjects treated for at least six months and 44 subjects treated for at least one year.  Common adverse events (>=2% in tasimelteon and greater than placebo) in placebo controlled studies (tasimelteon n=429, placebo n=203) included, (tasimelteon %, placebo %), Back pain (2.1%, 2.0%), Dreams (vivid or unusual), (2.6%, 0.5%), Diarrhea (2.3%, 1.0%), Dry Mouth (2.3%, 0.5%), Headache (9.6%, 7.4%), Nasopharyngitis (6.5%, 6.4%), Somnolence (3.0%, 1.5%), Upper Respiratory Tract Infection (2.6%, 1.5%).  In placebo controlled studies (tasimelteon n=429, placebo n=203), all seriou
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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
5. Vanda Presents Data From Tasimelteon Phase III Studies In Non-24-Hour Disorder
6. Vanda Announces Submission To FDA Of A New Drug Application For Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind
7. Vanda to Present Tasimelteon Non-24 Phase III Data at Two Medical Meetings
8. Vanda Reports Successful Completion Of Pre-NDA Meeting With FDA On Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind
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