Viatris Announces Positive Top-line Results from Phase 3 Study of EFFEXOR® in Japanese Adults with Generalized Anxiety Disorder (GAD)
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
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%).
Commonly observed TEAEs like nausea and somnolence were reported at a lower rate than outside of Japan.
