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Vanda says Phase III study data shows cortisol rhythm restoration

Vanda Pharmaceuticals presented additional data at ENDO 2013 demonstrating that tasimelteon can entrain both melatonin and cortisol rhythms. This effect further confirms tasimelteon's potential to reset the master body clock and address the circadian desynchrony which is inherent in Non-24-Hour Disorder. The SET and RESET Phase III studies were designed to assess the safety, efficacy and maintenance effect of tasimelteon for Non-24. Currently there is no approved FDA treatment for Non-24. In the SET study, tasimelteon achieved the primary endpoints of entrainment of the melatonin rhythm as compared to placebo and clinical response as measured by entrainment plus a score of greater than or equal to 3 on the Non-24 Clinical Response Scale. The RESET study demonstrated that continued treatment with 20mg of tasimelteon was required to maintain entrainment of melatonin and cortisol circadian rhythms in individuals with Non-24.