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梯瓦制药Nuvigil临床三期治疗抑郁症研究失败

  1. Nuvigil
  2. 抑郁症
  3. 梯瓦制药

来源:生物谷 2013-09-03 09:32

2013年9月2日讯 /生物谷BIOON/ --以色列著名制药商梯瓦公司日前宣布,公司研制的Nuvigil(armodafinil)用于治疗抑郁症的临床三期研究再次失败,公司被迫彻底放弃这一研究。这是公司在Nuvigil治疗抑郁症领域进行的第三次临床三期实验。此前Nuvigil已经获得FDA批准用于治疗过度嗜睡症。

2013年9月2日讯 /生物谷BIOON/ --以色列著名制药商梯瓦公司日前宣布,公司研制的Nuvigil(armodafinil)用于治疗抑郁症的临床三期研究再次失败,公司被迫彻底放弃这一研究。这是公司在Nuvigil治疗抑郁症领域进行的第三次临床三期实验。此前Nuvigil已经获得FDA批准用于治疗过度嗜睡症。

由于抑郁症药物研发领域的巨大花费和不确定性,许多大型药企如阿斯利康等已经完全退出这一领域。梯瓦公司的摇钱树Copaxone将于明年春天失去专利保护。(生物谷Bioon.com)

详细英文报道:

You can scratch another experimental depression drug off the list. Teva ($TEVA) today announced that it will dump its depression program for Nuvigil (armodafinil) after the treatment failed its latest Phase III test in a comparison against a placebo.

This was Teva's third Phase III study of Nuvigil for depression. Near the beginning of the year investigators for the company reported that the drug had flunked another late-stage showdown against a placebo. Faced with high, often hard-to-explain placebo responses in depression, drug companies are required to run multiple studies in search of positive data. The high cost and the extraordinary risk--which AstraZeneca ($AZN) can attest to as well--has caused several companies to steer clear of the field entirely.

"While this study demonstrated a numerical improvement, we are disappointed that armodafinil did not reach statistical significance. Teva remains committed to advancing science in serious conditions affecting the central nervous system," said Michael Hayden, Teva's president of global R&D.

The failure will have no material effect on the big generics company, according to the release, though the setback will do nothing to improve Teva's spotty record in R&D. Its cash cow Copaxone faces generic competition next spring, and analysts have been turning up the heat on the company to do something effective in terms of new product development. Nuvigil is already approved for excessive sleepiness.

 


 

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