Takeda and Lundbeck’s Multimodal Antidepressant Trintellix (Vortioxetine) Approved in Japan, Already Launched in China

September 21, 2019/BioValleyBIOON/-- Japanese pharmaceutical giant Takeda and its partner Lundbeck recently jointly announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the antidepressant drug Trintellix (Chinese brand name: Xindayue; generic name: vortioxetine), forDepressionand the treatment of depressive states. In Japan, approximately 3 millionDepressionPatients, accounting for approximately 2.5% of the total population. Trintellix will be used for severe cases in JapanDepression(MDD) patients a new treatment option with novel pharmacological properties. To date, vortioxetine has been approved in 83 countries worldwide, including the United States, Europe, and China.

Takeda and Lundbeck reached an agreement in 2007 on the joint development and potential co-commercialization of Lundbeck’s vortioxetine in Japan. According to communications in September 2018, Takeda and Lundbeck will jointly commercialize Trintellix in Japan following approval.

In September 2018, both parties submitted a New Drug Application (NDA) for Trintellix to the Ministry of Health, Labour and Welfare (MHLW). The NDA included data from a pivotal Phase III clinical study conducted in Japan (NCT02389816), as well as data from three additional pivotal studies conducted globally (NCT01255787) and in Japan (NCT01355081, NCT01395147). NCT02389816 was a randomized, placebo-controlled, double-blind, parallel-group trial involving 493 adult patients with major depressive disorder (MDD) in Japan. In this study, patients were randomized to receive vortioxetine 10 mg, vortioxetine 20 mg, or placebo. The primary endpoint was the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline (at the start of the double-blind phase) to Week 8 of treatment. The results demonstrated that vortioxetine had significant antidepressant efficacy compared with placebo in adult patients with MDD, with positive outcomes on the primary endpoint and statistically significant differences.

Vortioxetine acts as a serotonin (5-HT) reuptake inhibitor and modulates serotonin receptors (as an antagonist at 5-HT3, 5-HT7, and 5-HT1D receptors, a partial agonist at 5-HT1B receptors, and an agonist at 5-HT1A receptors). Vortioxetine is believed to regulate neurotransmission through multiple systems, including those involving serotonin, norepinephrine, dopamine, acetylcholine, and histamine. Vortioxetine is considered the first and only compound with this pharmacological profile.

Vortioxetine was approved in the United States in September 2013FDAApproved for marketing, it has currently received approval in over 80 countries worldwide, including China. In North America, it is marketed under the brand name Trintellix; in markets outside North America, it is marketed under the brand name Brintellix. The drug is available in 5 mg, 10 mg, and 20 mg tablets to meet the diverse needs of patients with major depressive disorder (MDD). InClinical TrialsIn China, Trintellix for the overallDepressionStatistically significant improvement in symptoms.

It is worth noting that the US drug label for Trintellix was updated twice last year:

—In May 2018, clinical data demonstrating improved processing speed were added. Processing speed is an important aspect of cognitive function in acute MDD and is impaired in many patients with MDD. This label update also makes Trintellix the first antidepressant to demonstrate a positive effect on processing speed in prescribing information.

—In October 2018, relevant clinical data on the improvement of sexual function were added.A common issue in the treatment of major depressive disorder (MDD) is that some medications can have adverse effects on sexual function, a condition referred to as treatment-emergent sexual dysfunction (TESD). TESD can affect any aspect of the sexual response cycle, including sexual desire, arousal, and orgasm. In clinical studies, patients treated with Trintellix demonstrated statistically significant improvements in sexual dysfunction (as measured by the total score on the CSFQ-14) from baseline to Week 8, compared to those treated with Lexapro (escitalopram), a commonly used selective serotonin reuptake inhibitor (SSRI). Throughout the study, both medications maintained the antidepressant benefits previously achieved with SSRI monotherapy.

In the Chinese market, vortioxetine was approved in December 2017CFDAApproved for the treatment of major depressive disorder in adults. In April 2018, the drug was launched and marketed under the brand name Brintellix® (vortioxetine hydrobromide tablets). As a novel multimodal antidepressant, Brintellix offers new options and hope to the vast number of patients with depression in China. China is one of the countries with a relatively high burden of depressive disorders globally. According to reports from the World Health Organization (WHO), more than 54 million people in China suffer from depression, accounting for 4.2% of the total population.

Major Depressive Disorder (MDD), also known as clinical depression, is a common and severe mental disorder and a leading cause of disability. According to WHO statistics, there are up to 300 million MDD patients worldwide. The condition is characterized by mood changes and other symptoms that can interfere with an individual’s ability to work, sleep, study, eat, and enjoy pleasurable activities.

Depressive episodes typically recur throughout a person’s life, although some individuals may experience only a single episode. Other signs and symptoms of the disorder include loss of interest in daily activities, significant changes in weight or appetite, insomnia or hypersomnia, psychomotor agitation (such as restlessness or pacing), fatigue, feelings of guilt or worthlessness, slowed thinking, impaired concentration, suicide attempts, or suicidal ideation. However, not all patients with major depressive disorder (MDD) experience the same symptoms. (Bioon.com)

Original Source:Takeda and Lundbeck announce Ministry of Health, Labour and Welfare (MHLW) approval of Trintellix® in Japan