OREANDA-NEWS. Takeda Pharmaceuticals U.S.A., Inc., a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), and Lundbeck announced today that Trintellix (vortioxetine), a once-daily oral antidepressant indicated for the treatment of major depressive disorder (MDD) in adults, is now available in United States pharmacies.

Takeda and Lundbeck recently announced that the trade name for the vortioxetine product in the United States would be changed to Trintellix to avoid name confusion. The formulation, indication and dosages of Trintellix remain the same as that of Brintellix, which was originally approved by the U.S. Food and Drug Administration (FDA) in September 2013. The companies, in coordination with the FDA, determined that a name change would be the best way to minimize future product name confusion by patients and providers.

The newly named Trintellix will have new National Drug Code (NDC) numbers associated with the product. Individuals and healthcare professionals who have questions about the name change, should contact Takeda at 1-877-TAKEDA-7.

The mechanism of the antidepressant effect of Trintellix is not fully understood. It is an inhibitor of serotonin (5-HT) reuptake and that is thought to be a mechanism of its action. It is also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors. The contribution of each of these activities to Trintellix’s antidepressant effect has not been established. It is considered to be the first and only compound with this combination of pharmacodynamic activity. The clinical relevance of this is unknown.

Trintellix was discovered by Lundbeck researchers in Copenhagen, Denmark. The clinical trial program in the United States was conducted jointly by Lundbeck and Takeda, and Takeda holds the new drug application for the U.S. market. Trintellix is a trademark of H. Lundbeck A/S and used under license by Takeda Pharmaceuticals America, Inc.

The World Health Organization has issued an Anatomical Therapeutic Chemical (ATC) code for Trintellix that places it in the category of “Other” antidepressants.

The most commonly observed adverse events in MDD patients treated with Trintellix in 6-8 week placebo-controlled studies (incidence greater than or equal to 5 percent and at least twice the rate of placebo) were nausea, constipation and vomiting. Overall, 5 to 8 percent of the patients who received Trintellix 5 to 20 mg/day in short-term trials discontinued treatment due to an adverse reaction, the most common being nausea, compared with 4 percent of placebo-treated patients in these studies. Trintellix and other antidepressants may cause serious side effects. See Important Safety Information below.

In clinical studies, Trintellix had no significant effect on body weight as measured by the mean change from baseline in 6-8 week placebo-controlled studies. In the 6-month, double-blind, placebo-controlled phase of a long-term study in patients who had responded to Trintellix during the initial 12-week, open-label phase, there was no significant effect on body weight between Trintellix and placebo-treated patients. Trintellix has not been associated with any clinically significant effects on vital signs, including systolic and diastolic blood pressure and heart rate, as measured in placebo-controlled studies.

The recommended starting dose of Trintellix is 10 mg once daily without regard to meals. The dose should then be increased to 20 mg/day, as tolerated, because higher doses demonstrated better treatment effects in trials conducted in the U.S. A dose decrease down to 5 mg/day may be considered for patients who do not tolerate higher doses. The available doses provide important flexibility for physicians to help address the variability of patient needs.