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ARTICLE | Clinical News

Tasimelteon: Additional Phase III data

January 28, 2013 8:00 AM UTC

Data from patients who responded to tasimelteon in the open-label run-in portion of the double-blind, U.S. Phase III RESET trial showed that continued treatment with once-daily 20 mg oral tasimelteon met the primary endpoint of a greater proportion of patients who maintained entrainment of the 6-sulphatoxymelatonin (aMT6s) rhythm to the 24-hour day vs. patients who switched to placebo (90% vs. 20%, p=0.0026). On secondary endpoints, a significantly greater proportion of patients who continued to receive tasimelteon achieved maintenance of entrainment of the cortisol rhythm vs. patients who switched to placebo (80% vs. 20%, p=0.0118). Maintenance treatment with tasimelteon also significantly improved mean LQ-nTST time (-6.6 vs. -73.8 minutes, where higher values indicate improvement, p=0.0233), UQ-dTSD time (-9.6 vs. 49.8 minutes, where lower values indicate improvement, p=0.0266) and MoST time (19.8 vs. -16.2 minutes, where higher values indicate improvement, p=0.0108) vs. placebo.

The trial enrolled 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 responded to treatment, as measured by the resetting and alignment of their body clock to the 24-hour day, were randomized to receive placebo or continue receiving tasimelteon for 2 months. Vanda plans to submit an NDA to FDA in mid-2013 for tasimelteon to treat non-24-hour sleep wake disorder. ...