Takeda, Lundbeck announce presentation of data from four studies that evaluate vortioxetine for MDD

May 20 2013

Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) today announced that the companies will be presenting new data from four studies that evaluated effectiveness in treating the overall symptoms of depression in patients taking vortioxetine, an investigational agent under review with the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). These data will be presented at the 2013 American Psychiatric Association Annual Meeting (APA) in San Francisco.

The objective of these four studies was to evaluate the efficacy and safety profile of vortioxetine in doses ranging from 10-20 mg per day, complementing other studies in the New Drug Application (NDA) submission package that included dose ranges of 5-20 mg per day. Three of the four pivotal studies met the primary efficacy endpoint as measured by the change from baseline of the Montgomery-Asberg Depression Rating Scale (MADRS) total score at week 8. Statistically significant improvements in overall symptoms of depression were demonstrated, as compared to placebo. A fourth study did not meet the primary endpoint. Results of all four studies provided additional information regarding the safety profile of vortioxetine.

"It is important that we continue to seek new options in depression because, even though there are effective treatments available, many patients remain symptomatic," said Madhukar Trivedi , M.D., professor of psychiatry, UT Southwestern Medical Center. "As a clinician, I'm encouraged by these data. They represent an important addition to the broader clinical profile for vortioxetine and support its potential as a new treatment for patients living with MDD."