Viatris Reports Positive Phase 3 Results for EFFEXOR® in Japanese Adults with GAD

Viatris Inc., a global healthcare leader, announced promising top-line results from its Phase 3 study (B2411367) in Japan, which evaluated the safety and efficacy of EFFEXOR® (venlafaxine) in adults suffering from generalized anxiety disorder (GAD). The study met its primary and all secondary efficacy endpoints, demonstrating the superiority of venlafaxine over placebo.

The primary objective focused on the anxiolytic effects of EFFEXOR® at an 8-week mark, comparing the change in the Hamilton Anxiety Rating Scale (HAM-A) total score from baseline. The results showed a statistically significant improvement with a two-sided p-value of 0.012, affirming the efficacy of venlafaxine. Additionally, all seven secondary efficacy endpoints were achieved, further confirming EFFEXOR®'s superiority over placebo.

EFFEXOR® exhibited a favorable safety profile in this study, consistent with its known safety parameters in non-Japanese patients. Low discontinuation rates due to treatment-emergent adverse events (TEAEs) were observed, with 7.3% for EFFEXOR® compared to 1.7% for placebo. Notably, only 3.9% of these were treatment-related compared to 0.6% for placebo. No serious TEAEs or those of severe intensity were recorded in the EFFEXOR® group, and there was a lower incidence of new suicidal ideation (2.8% vs. 5.1% in placebo). Common adverse events like nausea and somnolence were reported less frequently in the Japanese context than internationally.

Philippe Martin, Viatris Chief R&D Officer, expressed satisfaction with the results, highlighting the potential of EFFEXOR® as a significant treatment option for Japanese patients with GAD. He noted that the benefits observed underscore the medication's promise in addressing an unmet medical need in Japan, where no treatments for GAD are currently approved.

Sun-A Kim, Viatris Japan Country Manager, pointed out the general public's limited awareness of GAD in Japan, compounded by the lack of national clinical practice guidelines for its treatment. She emphasized Viatris Japan's commitment to addressing mental health disorders and welcomed the study's positive implications for the potential approval and use of EFFEXOR® in treating GAD.

Globally, selective serotonin reuptake inhibitors (SSRIs) and serotonin–norepinephrine reuptake inhibitors (SNRIs) are preferred first-line treatments for GAD. EFFEXOR® is approved in Japan for major depressive disorder in adults and for GAD in over 80 countries outside Japan.

The Phase 3 study was a randomized, double-blind, placebo-controlled, multicenter trial involving 357 Japanese outpatients diagnosed with GAD based on DSM-5 criteria. Participants were randomly assigned to receive a flexible dose of 75-225 mg/day of venlafaxine or a placebo once daily for eight weeks. The primary goal was to establish venlafaxine's anxiolytic superiority over placebo by evaluating the HAM-A total score change from baseline at 8 weeks. The trial also aimed to assess the safety and tolerability of venlafaxine.

Key secondary endpoints included measures such as the HAM-A psychic and somatic anxiety factors, Clinical Global Impressions-Severity of Illness (CGI-S), Clinical Global Impressions-Global Improvement (CGI-I), Generalized Anxiety Disorder 7 (GAD-7), Zung Self-Rating Anxiety Scale (ZSRAS), and Sheehan Disability Scale (SDISS).

Viatris is also conducting a long-term, open-label extension study over 52 weeks to further evaluate venlafaxine's safety and effectiveness in Japanese outpatients with GAD who completed the initial Phase 3 study. The results of this ongoing study are expected in 2025.

Generalized anxiety disorder (GAD), as defined by the World Health Organization, involves persistent and excessive worry about daily activities or events, affecting about 4% of the worldwide population. GAD significantly impairs quality of life and daily functioning, making effective treatment options crucial.

Viatris Inc. is a global healthcare entity with a mission to enable people to live healthier lives at all stages. With an extensive portfolio of medicines and a global supply chain, Viatris provides high-quality medications to around 1 billion patients annually, addressing diverse healthcare needs.