Viatris Submits Applications in Japan to Expand Effexor® Use for Anxiety Treatment
Tuesday, April 22, 2025
Viatris has submitted supplemental new drug applications to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking approval to use Effexor SR Capsules (venlafaxine hydrochloride) for treating adults with Generalised Anxiety Disorder (GAD).
GAD is a common mental health condition marked by persistent and excessive worry about everyday situations. Other symptoms may include sleep disturbances, muscle tension, restlessness, irritability, and difficulty concentrating. These can affect a person’s ability to function at work or in daily life.
If approved, Effexor would become the first treatment specifically approved for GAD in Japan.
The application is supported by results from a Phase 3, placebo-controlled, double-blind study conducted in Japan. The trial met its primary goal by showing that venlafaxine significantly reduced anxiety symptoms at eight weeks, as measured by the Hamilton Anxiety Rating Scale (HAM-A). All secondary outcomes in the trial were also achieved. Data from a long-term extension study was included in the submission.
In Japan, the World Health Organization estimates that 2.6% of people will experience GAD during their lifetime. However, a recent study using a screening tool (GAD-7 ≥ 10) found that 7.6% of respondents showed signs of probable GAD, suggesting the condition may be underdiagnosed.
Outside Japan, serotonin-noradrenaline reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) are commonly used as first-line treatments for GAD.
Effexor is already approved in Japan for major depressive disorder and is approved for GAD in more than 80 countries worldwide.
Source: viatris.com
