Phase III studies of VEC 162 (Vanda Pharmaceuticals) meet primary endpoint for Non-24 Hour Disorder

Data from SET and RESET Phase III studies of VEC 162 (tasimelteon), from Vanda Pharmaceuticals, for the treatment of Non-24-Hour Disorder (Non-24) in totally blind individuals shows it achieved the primary endpoints of entrainment (synchronizing) of the melatonin (aMT6s) 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 (N24CRS). 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 (CGI-C), 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 FDA is currently assessing an NDA for tasimelteon for Non-24 in blind people. Data was presented at SLEEP 2013.