Viatris has unveiled positive results from a Phase 3 study evaluating the safety and efficacy of Effexor (venlafaxine) in treating adults with generalised anxiety disorder (GAD) in Japan.
Effexor is a serotonin-norepinephrine reuptake inhibitor used to treat major depressive disorder, generalised anxiety disorder, panic disorder, and social anxiety disorder.
The randomised, double-blind, placebo-controlled, multicentre Phase 3 study was designed to evaluate the efficacy and safety of Effexor in 357 Japanese outpatients with GAD.
The study enrolled patients based on the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnostic criteria and Hamilton Anxiety Rating Scale (HAM-A) total score.
They were randomised equally to a flexible dose of 75-225mg/day Effexor or a once-daily, oral dosing placebo for an eight-week treatment period.
Viatris chief R&D officer Philippe Martin said: “We are very pleased with these top-line results, which consistently demonstrate the efficacy and safety of Effexor for the treatment of generalized 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, a condition which currently does not have any approved treatments available.
“This significant life cycle opportunity is yet another proof point of our diversified base business pipeline, which includes more than 70 novel products in development or under regulatory review.”
The Phase 3 study met its primary objective of Effexor showing superior anxiolytic effects compared to the placebo in eight weeks.
The superiority was measured based on the change in the Hamilton Anxiety Rating Scale (HAM-A) total score from baseline.
The study also met all seven secondary efficacy endpoints, as defined by the trial protocol, which confirmed the superiority of the drug, compared to placebo.
In this study, Effexor was generally well tolerated with a profile consistent with its known safety profile in non-Japanese patients.
Viatris is also conducting a long-term extension study of Effexor in Japanese outpatients with GAD who completed the Phase 3 study, with the study results expected in 2025.
Viatris Japan country manager Sun-A Kim 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 large unmet need in Japan for those living with and treating excessive anxiety and worry.
“Viatris Japan remains committed to meeting the needs of patients living with mental health disorders, and 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.”
