Viatris Inc., a global healthcare company, received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Effexor SR 37.5 mg / 75 mg capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor for the treatment of adults with generalized anxiety disorder (GAD). With the MHLW’s decision, Effexor becomes the first approved treatment option in Japan for GAD. Effexor is currently approved in Japan for the indication of major depressive disorder in adults.

The approval of Effexor for GAD is based on a Phase 3 placebo-controlled, randomized, double-blind, multicenter study of venlafaxine in patients with GAD conducted in Japan. 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. All seven secondary efficacy endpoints as defined by the trial protocol were met. Effexor was generally well tolerated with a profile consistent with its known safety profile in non-Japanese patients. 

These results and the results of a long-term extension study of venlafaxine in Japanese outpatients with GAD were included as part of the applications for approval. Effexor is currently approved to treat GAD in more than 80 countries outside of Japan.