Vanda Pharmaceuticals, Inc. (VNDA)

[surf1944]

6:56AM Vanda Pharma announces Phase IIb/III clinical study in major depressive disorder did not meet the primary endpoint (VNDA) 4.34 : Co announced top-line results of the Phase IIb/III clinical study (MAGELLAN) in Major Depressive Disorder (MDD), investigating the efficacy and safety of tasimelteon as a monotherapy in the treatment of patients with MDD. The clinical study did not meet the primary endpoint of change from baseline in the Hamilton Depression Scale (HAMD-17) after 8 weeks of treatment as compared to placebo. Both tasimelteon and placebo treated patients had an approximately 40% reduction of their MDD symptoms from baseline. Tasimelteon was shown to be safe and well-tolerated, consistent with observations in prior studies. Given these current proof of concept clinical study results, Vanda has decided to discontinue all activities in this indication. Vanda has recently reported positive results in two phase III clinical studies of tasimelteon in Non-24-Hour Disorder (Non-24) and plans to submit a New Drug Application to the FDA in mid-2013.