Vanda Announces Positive Phase III Study Results for Tasimelteon for Treatment of Non-24-Hour Disorder

Vanda Pharmaceuticals

, today announced positive results for the second Phase III study of tasimelteon for the treatment of Non-24-Hour Disorder (Non-24).  The RESET study (Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat Non-24-Hour Disorder), demonstrated the maintenance effect of 20mg of tasimelteon to entrain melatonin and cortisol circadian rhythms in individuals with Non-24.  Tasimelteon treated patients maintained their clinical benefits while placebo treated patients showed significant deterioration in measures of nighttime sleep, daytime naps, and timing of sleep.  Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally blind individuals who lack light perception and cannot entrain (reset) their master body clock to the 24-hour day.  Currently there is no approved treatment for Non-24. "These results clearly demonstrate that tasimelteon can entrain the circadian clock and continued treatment is necessary to maintain entrainment," said Steven W. Lockley, Ph.D., Division of Sleep Medicine, Brigham and Women's Hospital, a teaching affiliate of Harvard Medical School.  "The study also shows that entrainment is associated with meaningful clinical benefits and that maintaining entrainment of the