H. Lundbeck A/S and Takeda Pharmaceutical announce positive results from their pivotal study with vortioxetine in adults with Major Depressive Disorder conducted in Japan.
Both companies intend to move forward with regulatory filing of vortioxetine later this year to the Ministry of Health, Labor and Welfare in Japan.
In April 2015, Takeda initiated the clinical phase III placebo-controlled study (NCT02389816) in MDD. Approximately 490 patients with recurrent MDD were randomized to receive vortioxetine (10 and 20 mg) or placebo. The primary endpoint was the change from baseline (i.e. the start of double-blind treatment) in the Montgomery—Åsberg Depression Rating Scale (MADRS) total score after 8 weeks of treatment.