Viatris files applications in Japan for approval of Effexor to treat GAD

Effexor, a serotonin-noradrenaline reuptake inhibitor (SNRI), has shown promise in treating GAD in adults through a recent study in Japan.

The Phase III trial, Study B2411367, confirmed venlafaxine’s superior anxiolytic effects compared to placebo at eight weeks.

It met all seven secondary efficacy endpoints, reinforcing the application.

The data from this and a long-term extension study form the basis of the applications to the MHLW.

Viatris chief R&D officer Philippe Martin said: “The filing of our supplemental New Drug Applications is a key milestone as we move one step closer to bringing the first available treatment option for generalised anxiety disorder to adults in Japan.

“Positive results from our previously announced Phase 3 efficacy and safety studies laid the foundation for our applications with the MHLW. Effexor for GAD is among a number of novel assets we are advancing through our diversified pipeline to address significant unmet needs.”

GAD is characterised by excessive, persistent worry impacting daily life. Symptoms such as sleep disturbances, muscle tension and concentration difficulties can impair social and occupational functioning.

In Japan, this condition affects a notable percentage of the population, with studies indicating a prevalence of probable GAD at 7.6%.

Internationally, selective serotonin reuptake inhibitors (SSRIs) and SNRIs are the recommended first-line drug therapies for GAD.

Effexor is already approved for major depressive disorder in Japan and for GAD in over 80 countries.