Treatment with once-daily EFFEXOR ® met primary and all secondary efficacy endpoints in outpatient adults with GAD EFFEXOR ® was generally well tolerated, consistent with its known safety profile Pharmaceuticals and Medical Devices Agency (PMDA) submission targeted for 2025 PITTSBURGH and TOKYO , Oct. 9, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS ), a global healthcare company, today announced positive top-line results of its Phase 3 study (B2411367) in Japan evaluating the safety and efficacy of EFFEXOR ® (venlafaxine) in adults with generalized anxiety disorder (GAD).
The study 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 (HAM-A) total score from baseline (two-sided p-value=0.012). All seven secondary efficacy endpoints as defined by the trial protocol were met, which confirmed superiority compared to placebo.
In this study, EFFEXOR ® was generally well tolerated with a profile consistent with its known safety profile in non-Japanese patients. In particular: Low discontinuation rates due to treatment emergent adverse events (TEAEs) were seen (7.3% vs 1.
7% in placebo) with 3.9% vs 0.6% assessed as related to treatment.
No serious TEAEs or TEAEs with severe intensity were observed (0% vs 1.1% and 0.6%, respectively, in placebo).
Incidence of new suicidal ideation was lower in the EFFEXOR ® treatment group than in placebo (2.8% vs 5.1%).
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