Phase 3 Study Results Announced for Tasimelteon in Non-24-Hour Disorder

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Vanda Pharmaceuticals announced positive results for the second Phase 3 study of tasimelteon for the treatment of Non-24-Hour Disorder (Non-24). Patients treated with tasimelteon maintained their clinical benefits while placebo treated patients displayed significant deterioration in measures of nighttime sleep, daytime naps, and timing of sleep. Tasimelteon is a melatonin agonist of the human MT1 and MT2 receptors, with greater specificity for MT2. It has the ability to reset the master body clock in the suprachiasmatic nucleus, resulting in the entrainment of the body's melatonin and cortisol rhythms to align to the 24-hour day-night cycle.

RESET is a randomized withdrawal study designed to demonstrate the maintenance effect of 20mg of tasimelteon in the treatment of blind individuals with Non-24. Twenty patients were randomized to be treated with tasimelteon for three months during the open-label run-in phase. Patients who responded to tasimelteon during the run-in phase, were then randomized to receive either placebo or continue receiving tasimelteon 20mg for 2 months. The study met its primary endpoint of the maintenance of effect as measured by entrainment of the melatonin (aMT6s) rhythm (tasimelteon 90% vs. placebo 20%; P-value: 0.0026).

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