New medicine for depression! Takeda / Lingbei's new multi-mode mechanism new drug, tritellix, was approved in Japan and has been listed in China!

September 21, 2019 / bioun / - Takeda, a Japanese pharmaceutical giant, and lundbeck, a partner, recently jointly announced that the Ministry of health, labor and welfare of Japan (MHLW) has approved the antidepressant trinix (Chinese brand name: xindayue, generic name: vortioxetine, vothixetine) for the treatment of depression and depressive state In Japan, there are about 3 million patients with depression, accounting for about 2.5% of the total population Tritellix will provide a new treatment option with new pharmacological characteristics for patients with major depression (MDD) in Japan Up to now, vortioxetine has been approved in 83 countries around the world, including the United States, Europe, China, etc Takeda and Lingbei reached an agreement in 2007 on the joint development and potential co commercialization of Lingbei's vortixetine in Japan According to the communication in September 2018, Takeda and Lingbei will jointly commercialize tritellix in Japan after approval In September 2018, both parties submitted a new drug application (NDA) from trintellix to MHLW The NDA includes data from a key phase III clinical study in Japan (nct02389816), as well as data from three other key studies conducted in the world (nct01255787) and Japan (nct01355081, nct01395147) Nct02389816 is a randomized, placebo-controlled, double-blind, parallel controlled trial in 493 adult MDD patients in Japan In the study, patients were randomly assigned to the vortioxetine 10 mg, 20 mg or placebo group The primary end point was the change in the Montgomery Spielberg Depression Rating Scale (MADRS) score from baseline (at the beginning of double blindness) to week 8 of treatment The results showed that compared with placebo, vortioxetine had significant antidepressant effect in adult patients with MDD, and the main end point was positive, the data was statistically significant difference Vortioxetine has 5-hydroxytryptamine (5-HT) reuptake inhibitors and 5-hydroxytryptamine receptor regulatory effects (5-HT 3, 7, 1D receptor antagonists, 5-HT 1B receptor partial agonists, 5-HT 1A receptor agonists) Vortioxetine is believed to regulate neurotransmission through several systems including 5-HT, noradrenaline, dopamine, acetylcholine and histamine Vortioxetine is considered to be the first and only compound with this pharmacological activity Vortioxetine was approved by FDA in September 2013 and has been approved by more than 80 countries in the world, including China In North America, the brand name is tritellix; in markets outside North America, the brand name is britellix The drug specification includes 5mg, 10mg and 20mg tablets, which can meet the different needs of MDD patients In clinical trials, trinitrix significantly improved the overall depressive symptoms of MDD patients It is worth mentioning that tritellix's US drug label was updated twice last year: in May 2018, clinical data to improve processing speed was added Processing speed is an important aspect of cognitive function in acute MDD, which is impaired in many MDD patients The label update also makes tritellix the first antidepressant to show a positive impact on processing speed in prescription data ——In October 2018, clinical data on improving sexual function were added A common problem in the treatment of MDD is that some drugs will have a negative impact on sexual function, which is called drug-induced sexual dysfunction (tessd) Tesd can affect any aspect of the sexual response cycle, including sexual desire, sexual arousal and orgasm In the clinical study, compared with lexapro, a commonly used selective serotonin reuptake inhibitor (SSRI), patients treated with tritellix had a statistically significant improvement in sexual dysfunction (total score of csfq-14) from baseline to the 8th week; in the study, both drugs maintained the depression improvement effect of SSRI alone Trintellix: it was launched in China in April 2018, with the brand name of xindayue ® in the Chinese market, and vortioxetine was approved by CFDA in December 2017 for the treatment of adult depression In April 2018, the drug was marketed under the brand name of xindayue ® (voltacetin hydrobromide tablets) As a new multi-mode antidepressant, xindayue brings new choices and hopes for the majority of depression patients in China China is one of the countries with more serious burden of depression in the world According to the World Health Organization (who), more than 54 million people in China suffer from depression, accounting for 4.2% of the total population Severe depression (MDD) is also known as clinical depression, which is a common serious mental disorder, but also the main cause of disability According to who statistics, there are up to 300 million MDD patients in the world The disease is characterized by emotional changes and other symptoms that can interfere with a person's ability to work, sleep, study, eat and enjoy pleasant activities The onset of depression usually accompanies a person's life, although some people may experience it only once Other signs and symptoms of the disease include loss of interest in daily activities, significant changes in weight or diet, insomnia or drowsiness, restlessness / back and forth (agitation), fatigue, guilt or worthlessness, slow thinking, impaired attention, attempted suicide or suicidal thoughts However, not all MDD patients experience the same symptoms Original source: Takeda and lundbeck announcement Ministry of health, labour and welare (MHLW) approval of trintellix ® in Japan