Viatris announces Effexor study achieves primary objective

Viatris announced top-line results of its Phase 3 study in Japan evaluating the safety and efficacy of Effexor in adults with generalized anxiety disorder, or 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, or HAM-A, total score from baseline. 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, or TEAEs, were seen with 3.9% vs 0.6% assessed as related to treatment. No serious TEAEs or TEAEs with severe intensity were observed. Incidence of new suicidal ideation was lower in the Effexor treatment group than in placebo. Commonly observed TEAEs like nausea and somnolence were reported at a lower rate than outside of Japan. The company expects to present the full results from this Phase 3 study at a future medical congress.