Takeda Pharmaceutical and H. Lundbeck are presenting data from four studies that evaluated the safety and efficacy of treating the overall symptoms of depression in patients administered their investigational agent vortioxetine—which is under FDA review for the treatment of major depressive disorder (MDD)—at the American Psychiatric Association’s annual meeting being held in San Francisco this week.
Overall, the companies said three of the four trials met their primary efficacy endpoints, as measured by Montgomery-Åsberg Depression Rating Scale (MADRS) total scores. “Statistically significant improvements in overall symptoms of depression were demonstrated, as compared to placebo,” the companies said of those three studies.
In one of those investigations, a randomized, double-blind, placebo-controlled study of vortioxetine 10 mg and 20 mg in adults with MDD, the companies found that the higher dose met statistical significance for MADRS score, while the lower dose did not.
That the fourth study of vortioxetine 10 mg and 15 mg in adults with MDD did not meet its primary endpoint, suggests that higher doses are more likely to be effective.
Though there are plenty of treatment options for MDD already on the market, Takeda and Lundbeck aim to make vortioxetine a viable choice for patients.
“It is important that we continue to seek new options in depression because, even though there are effective treatments available, many patients remain symptomatic,” UT Southwestern Medical Center’s Madhukar Trivedi, M.D., professor of psychiatry, said in a statement. Trivedi, who serves as scientific advisor for Takeda and Lundbeck, added: “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.”
