Tasimelteon: Phase III data

The double-blind, U.S. and German Phase III SET trial in 84 blind patients with non-24-hour sleep wake disorder showed that once-daily 20 mg oral tasimelteon for 6 months met the co-primary endpoint of a greater proportion of patients achieving entrainment (synchronization) of the endogenous circadian melatonin rhythm to the 24-hour clock vs. placebo (20% vs. 2.6%, p=0.0171). Tasimelteon also met the co-primary endpoint of improving clinical response rate at 6 months, as measured by achieving entrainment plus an N24CRS score of >=3 points, vs. placebo (23.7% vs. 0%, p=0.0028). On secondary endpoints, a significantly greater proportion of patients receiving tasimelteon achieved entrainment of the cortisol rhythm vs. placebo (17.5% vs. 2.6%, p=0.0313). Tasimelteon also significantly improved mean N24CRS scores (1.77 vs. 0.67 points, p=0.0004), CGI-C scores (2.6 vs. 3.4 points, p=0.0093), LQ-nTST time (57 vs. 16.8 minutes, p=0.0055), UQ-dTSD time (-46.2 vs. -18 minutes, p=0.005) and MoST time (34.8 vs.14.4 minutes, p=0.0123) vs. placebo. For the CGI-C and UQ-dTSD endpoints, Vanda said lower numbers indicate improvement. Tasimelteon was well tolerated. ...