Vanda Pharmaceuticals, Inc. (VNDA)

[surf1944]

6:31AM Vanda Pharma announces 'positive' results in the second Phase III study (RESET) of tasimelteon for the treatment of non-24-Hour disorder; tasimelteon significantly maintains entrainment of circadian rhythms (VNDA) 4.12 : Co announced positive results for the second Phase III study of tasimelteon for the treatment of Non-24-Hour Disorder (Non-24). The RESET study (Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat Non-24-Hour Disorder), demonstrated the maintenance effect of 20mg of tasimelteon to entrain melatonin and cortisol circadian rhythms in individuals with Non-24. Tasimelteon treated patients maintained their clinical benefits while placebo treated patients showed significant deterioration in measures of nighttime sleep, daytime naps, and timing of sleep. The RESET study demonstrates the efficacy of chronic treatment with tasimelteon in Non-24 and further supports the results of the SET study, which established the ability of tasimelteon to entrain the master body clock and significantly improve the clinical symptoms of Non-24. Co plans to submit a New Drug Application (NDA) to the FDA in mid-2013. Co will meet with the FDA in Q1 of 2013 for a pre-NDA meeting on tasimelteon in the treatment of patients with Non-24.