Viatris Inc (Nasdaq:VTRS), a US-based global healthcare company, announced on Monday that it has filed applications to Japan's Ministry of Health, Labor and Welfare (MHLW) for approval of Effexor SR Capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI) to treat adults with generalised anxiety disorder (GAD), an indication for which no other treatment option is currently approved in Japan.

Viatris reported previously that its Phase 3 placebo-controlled, randomised, double-blind, multicentre study of venlafaxine in patients with GAD conducted in Japan achieved its primary objective of superiority of anxiolytic effects of venlafaxine compared to placebo at 8 weeks, based on the change in the Hamilton Anxiety Rating Scale (HAM-A) total score from baseline (two-sided p-value=0.012). All seven secondary efficacy endpoints as defined by the trial protocol were met. These and results from a long-term extension study of venlafaxine in Japanese outpatients with GAD were included as part of the applications.

Outside Japan, selective serotonin reuptake inhibitors (SSRIs) and SNRIs are recommended as first-line drug therapies for patients diagnosed with GAD. Effexor is currently approved in Japan for major depressive disorder in adults. Effexor has also been approved for the indication of GAD in more than 80 countries outside Japan.

"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," said Viatris chief R&D officer Philippe Martin. "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."