Phase 3 Study Results Announced for Melatonin Agonist in Non-24-Hour Disorder
Vanda Pharmaceuticals announced positive results from the SET (Safety and Efficacy of Tasimelteon) Phase 3 study, evaluating tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24). Tasimelteon is a melatonin agonist of the MT1 and MT2 receptors.
The SET study was an 84 patient randomized, double-masked, placebo-controlled trial. Tasimelteon succeeded in the primary endpoint of Entrainment of the melatonin (aMT6s) rhythm as compared to placebo. Additionally, tasimelteon demonstrated significant improvements across a number of sleep and wake parameters including measures of total sleep time, nap duration, and timing of sleep. Tasimelteon also showed significant improvements over placebo in the Non-24 Clinical Response Scale (N24CRS) as well as in the Clinical Global Impression of Change (CGI-C), an overall global functioning scale.
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