FDA Approves Unique Multimodal Vortioxetine for Major Depressive Disorder


FDA Approved Vortioxetine 508233-74-7The approval of Vortioxetine CAS# 508233-74-7 came as exciting news at the close of September 2013. Known as the brand name Brintellix, Vortioxetine is marketed by Lundbeck and Takeda Pharmaceuticals. The FDA approval of this antidepressant is encouraging for both patients suffering from Major Depressive Disorder and the practitioners who treat these patients, as Vortioxetine offers a dual response mechanism of action. The multimodal action of Vortioxetine works by not only blocking serotonin reuptake, but it also aids in modulating serotonin receptor activity. This novel combination of complementary mechanisms makes Vortioxetine particularly useful for treating patients with Major Depressive Disorder who have failed to respond to first line treatment SSRI or SNRI antidepressants.

Studies of Vortioxetine have demonstrated success, based on the unique ability of this antidepressant to act as an antagonist for 5-HT7 and 5-HT3 receptors. Vortioxetine is also a formidable agonist for 5-HT1A and a partial agonist for 5-HT1B receptors. Lundbeck reported that 8 out of 10 of Phase lll  studies showed significant improvement in patients who received Vortioxetine versus the participants who received the placebo. Additional positive data emerged from a multicenter Phase lll trial, which was published in the International Clinical Psychopharmacology journal, which showed consistent successful results after treating an elderly patient group of participants ages 65 and older. The patients in this Phase lll study suffered from recurrent depressive disorder and were in dire need of different and effectual treatment. There were six clinical studies that led to the decision by the FDA to approve the immediate use of Vortioxetine.

Currently dispensed as Brintellix, Vortioxetine is available as 5, 10 and 20 milligram tablets. Titration is recommended, with the starting dose for the majority of adults starting with a dose of 10 milligrams. Adverse reactions were minimal, with nausea being the chief complaint from a small number of patients. The often reported “fuzzy” head and cognitive side effects, typically reported from patients who take antidepressants, were nonexistent for patients who were treated with Vortioxetine. One specific study, published in Clinical Pharmacology and Therapeutics in June 2013, offered promising data. This randomized study focused on the effects of antidepressants Vortioxetine and Mirtazapine on cognitive and driving abilities. Participants in this study were administered either 10 milligrams of Vortioxetine, 30 milligrams of Mirtazapine, which is a comparable dose, or a placebo pill.  The 24 participants were then assessed as to the effects of the antidepressant on their cognitive functions, driving abilities, and psychomotor performance. The patients who received Mirtazapine displayed impairment, both psychomotor and cognitive when assessed on the second day of the study. There were no patients who experienced any impairment in cognitive, driving or psychomotor skills from the group who received Vortioxetine, at any time during this fifteen day study.

According to the World Health Organization Major Depressive Disorder affects roughly 121 million people worldwide, and often proves to be a debilitating illness for many of these patients. Only about one-third of the patients with Major Depressive Disorder experience remission from their symptoms after first stages of treatment, leaving two-thirds of patients to experience an unsuccessful treatment outcome. Vortioxetine appears to be a viable option for this hard to treat patient population.

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