Aerjian kelitazide in the treatment of bipolar I depression in the second critical phase III clinical success
December 19, 2017 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Irish drugmaker Allergan and partner Hungarian pharmaceutical company Gedeon Richter recently announced the new antipsychotic drug Vraylar (cariprazine) for the treatment of bipolar I-type affective disorder-related major depressive episodes ( Phase III clinical study of biphasic type I depression in adult patients. Positive top line data for RGH-MD-54. The study was also the second critical phase III study to evaluate Vraylar's positive efficacy data for adult patients with bipolar type 1 depression.
RGH-MD-54 is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, fixed-dose phase III study conducted in 488 adult patients with bipolar I depression who were evaluated for 2 doses Efficacy, safety and tolerability of Vraylar (1.5 mg/day, 3.0 mg/day) versus placebo. In the study, all patients entered the drug-free screening period of approximately 7-14 days, followed by a 6-week double-blind treatment period, followed by a 1-week, drug-free, safe follow-up period.
The data showed that both doses of Vraylar (1.5 mg/day, 3.0 mg/day) reached the primary efficacy endpoint: two doses of Vraylar compared the Montgomery and Asperger Depression Rating Scale (MADRS) compared to placebo. A statistically significant improvement (p < 0.05) was achieved from the baseline to the 6th week of treatment. In this study, Vraylar was generally well tolerated. The most common adverse events (incidence ≥ 5%) include sedation, lethargy, dizziness, sedation, and nausea. In the Vraylar treatment group, 5% of patients discontinued treatment due to adverse events, and the proportion of the placebo group was 2.5%.
According to the positive data obtained in the Phase III clinical project, Ai Jian and Jirui Medical plan to submit Vraylar's new drug application (sNDA) for the treatment of bipolar I type depression in the second half of 2018.
David Nicholson, chief research officer at Aerjian, said that these phase III clinical data provide further support for Vraylar in the treatment of adult patients with bipolar I depression, and also add more clinical data to the treatment of mental health disorders. Ai Jian is looking forward to working closely with the FDA to submit Vraylar for the treatment of bipolar I sNDA as soon as possible.
Gary Sachs, associate professor of psychiatry at Harvard Medical School, said that the drugs currently approved for the treatment of bipolar depression are limited, and that the drugs that are investigated or approved to treat bipolar disorder from mania to depression are rare. For psychiatric social groups and patient groups, if another product is proven to treat a wide range of bipolar disorder, this would be a welcome addition to the patient's current treatment plan. The data released this time is an important milestone for Vraylar in the treatment of bipolar type I depression, and is also expected to broaden the treatment of Vraylar.
Bipolar disorder affects approximately 3.6 million people in the United States. Bipolar I type of affective disorder, also known as bipolar disorder, patients experience "emotional seizures", including: manic episodes (excessive excitement, extreme irritability, such as dizziness, difficulty sleeping), depressive episodes (extreme sadness, fatigue, despair) And mixed episodes (2 combined with mania and depression). Among them, bipolar type I depression is a serious type of damage to bipolar I type affective disorder.
Cariprazine is an oral, once daily atypical antipsychotic. In the United States, the drug was approved for sale under the brand name Vraylar in 2015. The currently approved indications include: (1) Emergency for manic or mixed episodes of adult patients with bipolar I disorder (manic depression) For treatment, the recommended dosage range is 3-6 mg/day; (2) for the treatment of adult patients with schizophrenia, the recommended dosage range is 1.5-6.0 mg/day. In the European Union, the drug is marketed under the brand name Reagila.
The mechanism of action of carilazide in the treatment of schizophrenia and bipolar I type affective disorder is unclear, possibly through partial antagonism of central dopamine D2 and serotonin 5-HT1A receptors and agonism of serotonin 5-HT2A receptor The activity of the agent is comprehensively mediated. Pharmacodynamic studies have shown that cariprazine, as a partial agonist, binds dopamine D3, dopamine D2, and 5-HT1A receptors with high affinity. In in vitro studies, the affinity of carilaazine for the D3 receptor is eight times that of the D2 receptor. At the same time, cariprazine can also act as an antagonist with high/moderate affinity for serotonin 5-HT2B and T-HT2A receptors, histamine H1 receptor, but for 5-HT2C and α1A-adrenergic receptors. The body has a lower affinity binding and no significant affinity for adrenergic receptors. The clinical significance of these in vitro studies is currently unclear.
Calixazine was discovered and co-developed by Jerry Medicine, and Aerjian authorized the exclusive right to the drug in the United States and Canada. Over the past 10 years, the two sides have conducted more than 20 clinical studies and enrolled thousands of people with mental illness worldwide to evaluate the efficacy and safety of cariprazine in the treatment of a wide range of psychiatric disorders. (Sina Pharmaceutical Compilation/newborn)
Article Reference Source: Allergan and Richter Announce Positive Topline Results from Phase 3 Study of Cariprazine for the Treatment of Bipolar I Depression
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