Viatris Reports Positive Phase 3 Results for EFFEXOR® A Treatment For Generalized Anxiety Disorder

Viatris Inc., a global healthcare company, announced positive top-line results from its Phase 3 study (B2411367) in Japan, which assessed the safety and efficacy of EFFEXOR® (venlafaxine) in adults with generalised anxiety disorder (GAD). The study met its primary objective, showing that venlafaxine was significantly more effective than placebo at eight weeks, as measured by the Hamilton Anxiety Rating Scale (HAM-A) (p-value=0.012). All seven secondary efficacy endpoints were also achieved, reinforcing its superiority over placebo.

EFFEXOR® was generally well tolerated, with low discontinuation rates due to treatment-emergent adverse events (TEAEs) (7.3% for EFFEXOR® vs. 1.7% for placebo), and no severe TEAEs were observed. Additionally, fewer instances of new suicidal ideation occurred in the EFFEXOR® group compared to placebo (2.8% vs. 5.1%). Common side effects like nausea and drowsiness were reported less frequently in Japan than in other countries.

"We are very pleased with these top-line results, which consistently demonstrate the efficacy and safety of EFFEXOR® for the treatment of generalised anxiety disorder in Japanese patients with moderate to severe disease. The benefit-risk profile observed with EFFEXOR® in this study underscores its potential as a meaningful treatment option for patients with GAD in Japan. This condition currently has no approved treatments available," stated Philippe Martin, Viatri's Chief R&D Officer. "This significant life cycle opportunity is another proof point of our diversified base business pipeline, which includes more than 70 novel products in development or under regulatory review. Our focused execution of this robust pipeline gives us confidence in our ability to continue to grow our base business and address unmet medical needs."

Sun-A Kim, Country Manager of Viatris Japan, said."Despite generalised anxiety disorder being well-recognized globally, there is a large, general public awareness gap of GAD in Japan. Exacerbating this gap is the absence of national clinical practice guidelines for treating the disease, signalling a significant unmet need in Japan for those living with and treating excessive anxiety and worry," also continued saying, "Viatris Japan remains committed to meeting the needs of patients living with mental health disorders. We are pleased to see that the results from this study signal the potential of EFFEXOR® to further reach patients as a possible treatment of GAD, for which there are currently no approved therapies in Japan."

Outside Japan, SSRIs and SNRIs are typically first-line treatments for GAD. EFFEXOR® is already approved for major depressive disorder in Japan, and it has been approved for GAD in over 80 countries. Viatris plans to present the full study results at an upcoming medical congress.