Viatris Inc. announced positive top-line results from its Phase 3 study (B2411367) evaluating EFFEXOR® (venlafaxine) in Japanese adults with Generalized Anxiety Disorder (GAD). The study successfully met its primary objective, demonstrating the superiority of venlafaxine's anxiolytic effects compared to placebo at 8 weeks.
The primary endpoint, based on the change in the Hamilton Anxiety Rating Scale (HAM-A) total score from baseline, showed a statistically significant difference with a two-sided p-value of 0.012. All seven secondary efficacy endpoints, as defined by the trial protocol, were also met, further confirming the drug's superiority over placebo.
EFFEXOR® was generally well tolerated in the study, exhibiting a safety profile consistent with its known characteristics in non-Japanese patients. These results underscore the drug's potential as a meaningful treatment option for patients with GAD in Japan, a condition for which no approved treatments are currently available.
Viatris plans to target a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) in 2025. This strategic move aims to address a significant unmet medical need in Japan and represents a key life cycle opportunity within the company's diversified base business pipeline.
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