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百时美施贵宝抑郁药BMS-820836 II期试验失败

来源:生物谷 2013-08-13 13:34

2013年8月13日讯 /生物谷BIOON/ --百时美施贵宝(BMS)及合作伙伴Albany Molecular  Research公司8月12日宣布,已终止实验性抑郁症药物BMS-820836的II期临床试验。该药由Albany开发,由百时美施贵宝推进临床试验。然而,临床试验中,该药未实现超过现有治疗方案的临床益处。

BMS-820836针对的是难治性抑郁症(TRD),这类患者对已上市的其他疗法不响应。在2个IIb期临床试验中,BMS-820836未表现出超过度洛西汀(duloxetine,Cymbalta)或依地普仑(escitalopram,Lexapro)的临床益处。

百时美施贵宝与Albany公司于2005年达成合作协议,截止2012年底,Albany已获得超过1500万美元的付款。

BMS-820836旨在作用于3种神经递质:5-羟色胺,去甲肾上腺素、多巴胺。

Albany公司称,将与百时美施贵宝讨论寻求在其他中枢神经系统(CNS)相关疾病中进行进一步药物测试的可能性。(生物谷Bioon.com)

英文原文:Experimental Depression Drug From Bristol-Myers Squibb Fails In Mid Stage Clinical Trials

By Jonathan Weiss | Aug 12, 2013 07:31 PM EDT Bristol-Myers Squibb (BMS) and its partner Albany Molecular Research recently announced the termination of clinical trials for a drug which was hoped to help bring in the next generation in depression treatments. The drug, code-named BMS-820836, was developed by Albany Molecular and was being pushed through clinical trials by BMS. However, it showed no benefit over existing treatments according to an Securities and Exchange Commission 8K filing by Albany Molecular.

The drug was targeted at Treatment Resistant Depression (TRD), in which patients did not respond to other therapies on the market. BMS-820836 showed no benefit over duloxetine (Cymbalta), an SNRI, or escitalopram (Lexapro), an SSRI, in patients with TRD during two phase IIb clinical trial studies (here and here).

The agreement that BMS would further develop the drug and run the clinical trials was agreed upon in 2005. The data from the failed clinical trial is expected to be shared at a conference in the future to try to explain the reason for the lack of superiority to the other current treatments. Albany Molecular had receive over $15 million from the agreement, as of the end of 2012.

The drug was designed to work on three neurotransmitters: serotonin, norepinephrine, and dopamine (i.e., a Triple Reuptake Inhibitor) and was meant as a four pill a day treatment.

Depression is a notoriously difficult disease to treat. Even with the many drugs currently on the market, not all patients find one that helps them to deal with their particular brain chemistry imbalance. Drugs for depression garner billions of dollars in sales yearly, in the U.S. alone, with one in ten adults reporting some level of depression at least once a year, according to the Centers for Disease Control and Prevention.

Albany Molecular will discuss with BMS about possibly pursuing further drug testing for other Centeral Nervous System (CNS) related diseases.

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