2:05AM Vanda Pharma presents data from Phase III studies that demonstrate Tasimelteon restores daily cortisol rhythm in blind patients with non-24-hour disorder (VNDA) 11.23 : Co presents data 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.
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. Tasimelteon also demonstrated significant improvement versus placebo across a number of sleep and wake parameters including measures of total sleep time, nap duration, and timing of sleep, as well as in the Clinical Global Impression of Change, an overall global functioning scale. In treated patients, 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 continued treatment with 20mg of tasimelteon was required to maintain entrainment of melatonin and cortisol circadian rhythms in individuals with Non-24. Patients treated with tasimelteon maintained their clinical benefits while patients who received placebo showed significant deterioration in measures of nighttime sleep, daytime naps and timing of sleep. Furthermore, discontinuation of tasimelteon resulted in a rapid relapse to misaligned circadian rhythms, reinforcing the importance of chronic therapy.
