Viatris (VTRS) announced it has filed applications to the Ministry of Health, Labor and Welfare for approval of Effexor SR Capsules, a serotonin-noradrenaline reuptake inhibitor to treat adults with generalized anxiety disorder, an indication for which no other treatment option is currently approved in Japan. As previously announced, our Phase 3 placebo-controlled, randomized, double-blind, multicenter study of venlafaxine in patients with GAD conducted in Japan achieved its primary objective of superiority of anxiolytic effects of venlafaxine compared to placebo at 8 weeks, based on the change in the Hamilton Anxiety Rating Scale total score from baseline. All seven secondary efficacy endpoints as defined by the trial protocol were met. These results and results from a long-term extension study of venlafaxine in Japanese outpatients with GAD were included as part of the applications.
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