Positive clinical phase III results of vortioxetine in Japanese patients

• New clinical phase III data from a study conducted in Japan demonstrate positive results of vortioxetine as compared to placebo for the treatment of Major Depressive Disorder (MDD) in Japanese adults
• Positive results suggest that vortioxetine may be a potential treatment option for Japanese adults with MDD in the future
• Based on the current data package, Lundbeck and Takeda intend to initiate the process for registration in Japan

Osaka, Japan, and Valby, Denmark, June 08, 2018 – Takeda Pharmaceutical Company Limited [TSE: 4502] (“Takeda”) and its partner, H. Lundbeck A/S (“Lundbeck”) today announced positive results from the pivotal study (NCT02389816) with vortioxetine in adults with Major Depressive Disorder (MDD) 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 randomized, placebo-controlled study (NCT02389816) in MDD. Approximately 490 Japanese adults 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. 

About Major Depressive Disorder (MDD)

MDD is a complex mental health illness that affects approximately 300 million people globally¹. Also known as clinical depression, MDD is the leading cause of disability worldwide and a major contributor to the overall global burden of disease. MDD may trigger emotional, cognitive and physical symptoms, which includes depressed mood, loss of interest or pleasure, significant weight loss or gain or change in appetite, insomnia or hypersomnia, psychomotor agitation or retardation, fatigue or loss of energy, feelings of worthlessness or excessive guilt, diminished ability to think or concentrate, or indecisiveness, and recurrent suicidal ideation.

About vortioxetine

The mechanism of the antidepressant effect of vortioxetine 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-HT_1A receptors, a partial agonist at 5-HT_1B receptors and an antagonist at 5-HT₃, 5-HT_1D and 5-HT₇ receptors. The contribution of each of these activities to vortioxetine’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.

Vortioxetine was discovered by Lundbeck researchers in Copenhagen, Denmark. The clinical trial program in Japan was conducted by Takeda.

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

The U.S Food and Drug Administration (FDA) approved vortioxetine (Trintellix^®) on 30 September 2013 for the treatment of MDD in adults. Vortioxetine is furthermore approved in 77 countries (including Europe, Canada, Chile, China, Mexico, Argentina, South Korea, Turkey, Australia, Hong Kong, Singapore and South Africa). It is available in more than 60 countries to date. Outside North America, vortioxetine is recognized as Brintellix^®.

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