Viatris Inc. (NASDAQ: VTRS) announced that Japan's Ministry of Health, Labour and Welfare approved Effexor SR capsules for treating generalized anxiety disorder in adults. The approval makes Effexor the first and only approved treatment option for GAD in Japan.

The drug, containing venlafaxine hydrochloride, is a serotonin-noradrenaline reuptake inhibitor already approved in Japan for major depressive disorder. Effexor is approved to treat GAD in more than 80 countries outside Japan.

The approval was based on a Phase 3 placebo-controlled study conducted in Japan that achieved its primary objective of demonstrating superior anxiety reduction compared to placebo at eight weeks. The study measured changes in the Hamilton Anxiety Rating Scale total score from baseline, with results showing statistical significance (p-value=0.012). All seven secondary efficacy endpoints were met.

In the study, discontinuation rates due to treatment-related adverse events were 7.3% for Effexor versus 1.7% for placebo, with 3.9% versus 0.6% assessed as treatment-related. No serious adverse events or severe intensity events were observed in the Effexor group, compared to 1.1% and 0.6% respectively in the placebo group.

GAD affects an estimated 7.6% of Japan's general population according to a recent study, though the World Health Organization reports that 2.6% of the population will experience GAD in their lifetime. The condition involves chronic anxiety about everyday events and can impair social and occupational functioning.

The information is based on a company press release statement.