2013年9月1日讯 --全球最大的仿制药生产商梯瓦（Teva），8月30日公布了Nuvigil（armodafinil）III期临床项目3个III期研究中最后一个研究的数据，该项目评价了Nuvigil作为一种辅助疗法用于治疗重度抑郁症和双相I型障碍的疗效。该项研究，在几个重要的次要终点取得了统计学意义显着差异，如响应速度和缓解，但未达到研究的主要终点，作为情绪稳定剂和/或非典型抗精神病药物的辅助疗法，Nuvigil未能比安慰剂更有效。

梯瓦同时宣布，将不再寻求Nuvigil用于治疗重度抑郁症和双相I型障碍的相关监管申请。

尽管在首个III期研究中，Nuvigil取得了阳性数据，但在第2个III期研究（Study 3072）中也失败了，未能达到研究的主要终点和次要终点。

此前，分析师预测，目前市面上已有数个抗抑郁药，Nuvigil上市的机会不大。

礼来（Eli Lilly）的药物Symbyax已获批用于治疗双相情感障碍所致的抑郁症。其他一些作为辅助治疗的药物，包括阿斯利康（AstraZeneca）的斯瑞康XR（Seroquel XR）和葛兰素史克（GSK）的利必通（Lamictal）。

晨星公司分析师分析称，鉴于Nuvigil的专利将于2016年到期，即便该项III期研究进展顺利，梯瓦也仅有很短的时间来销售该药。

目前，Nuvigil已获批用于睡眠障碍的治疗，该药在2012年的销售额为3.47亿美元。

Teva to drop depression treatment after trial fails

(Reuters) - Generic drugmaker Teva Pharmaceutical Industries Ltd said it will stop the development of a depression treatment after a late-stage trial failed to show the drug was more effective than a placebo.

The third late-stage study tested Nuvigil, or armodafinil, as an adjunct therapy in adults with major depression associated with bipolar I disorder.

While the first late-stage trial had positive results, the second trial had failed.

Analysts said the drug did not present much of an opportunity for Teva in a market where antidepressants for bipolar disorder are already available.

"If (the trial) had worked, Teva would have had to commit a lot of additional capital to compete in the market place," Maxim Group analyst Jason Kolbert said.

Eli Lilly's drug Symbyax is approved for the treatment of depression caused by bipolar disorder.

Other drugs used as adjunct therapies include AstraZeneca Plc's Seroquel XR and GlaxoSmithKline's Lamictal.

Given that Nuvigil's patent would expire in 2016, the company would have had a very short time to market the drug even if the trial had gone well, said Morningstar analyst Michael Waterhouse.

The drug is already approved to treat sleep disorders and accounted for $347 million, or 2 percent, of the company's revenue in 2012, according to a regulatory filing.

"The silver lining to Teva's failure is that the associated marketing expenditures now are halted and therefore, Teva can focus its capital on those priorities that represent unmet medical needs" Kolbert said.

Teva said there will be no material impact to the company. The company's US-listed shares were up slightly at $38.43 in afternoon trading.

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