Tasimelteon: Preliminary Phase III data

Vanda said preliminary data from the run-in portion of the double-blind, U.S. Phase III RESET trial showed that once-daily 20 mg oral tasimelteon reset the body clock and aligned 4 blind patients with non-24-hour sleep wake disorder to a constant 24-hour day. The company said the period of the body clock is measured by determining the timing of peak levels of the sulfate metabolite of melatonin in four 48-hour urine collections taken at 1-week intervals and that period lengths of >24 hours are seen in blind subjects with non-24-hour sleep wake disorder. The trial is enrolling 20 blind patients without light perception who have a body clock period of >24 hours to receive once-daily tasimelteon for 3 months in the run-in portion of the trial. Patients who respond to treatment, as measured by the resetting and alignment of their body clock to the 24-hour day, will then be randomized to receive placebo or continue receiving tasimelteon for 2 months. ...