Viatris has announced that the Ministry of Health, Labour and Welfare has approved Effexor SR (venlafaxine hydrochloride) capsules for the treatment of adults with Generalised Anxiety Disorder (GAD). The approval marks the first and only authorised treatment option for GAD in Japan, addressing a significant unmet need in mental healthcare.

Effexor SR, a serotonin-Noradrenaline Reuptake Inhibitor (SNRI), is already approved in Japan for major depressive disorder. With this expanded indication, the therapy is now available to a broader patient population suffering from anxiety-related conditions.

GAD is a common and debilitating mental health disorder that significantly impacts quality of life and daily functioning. Recent estimates suggest that approximately 7.6 percent of the general population in Japan may be affected by the condition.

The approval is supported by data from a Phase III randomised, double-blind, placebo-controlled study conducted in Japan, which demonstrated statistically significant improvement in anxiety symptoms at eight weeks compared to placebo, as measured by the Hamilton Anxiety Rating Scale. All secondary endpoints were also met, reinforcing the drug’s efficacy.

Effexor was generally well tolerated in the study, with low discontinuation rates due to adverse events and no serious treatment-related safety concerns reported. The safety profile was consistent with existing global data.

The company noted that the approval reflects its strategy to enhance its portfolio in Japan by expanding the use of established therapies to meet unmet clinical needs. Effexor is already approved for GAD treatment in more than 80 countries worldwide.