礼来抑郁症药物edivoxetine III期项目失败

礼来（Eli Lilly）12月5日宣布，有关实验性抑郁症药物edivoxetine的3个III期研究（LNBM，LNBQ，LNBR）均未达到研究的主要终点。这些研究在重度抑郁症（MDD）患者中开展，将edivoxetine或安慰剂添加至一种选择性血清素再摄取抑制剂（SSRI）进行治疗8周后，与安慰剂相比，edivoxetine未能改善蒙哥马利-艾森贝格抑郁量表（MADRS）总评分。

这些研究中，edivoxetine的安全性和耐受性与既往研究一致，研究的疗效数据不支持edivoxetine作为重度抑郁症（MDD）辅助治疗药物的监管意见书。这些研究的数据，将在2014年的科学论坛公布。

2010年，礼来启动了edivoxetine的III期项目，评估edivoxetine作为辅助治疗药物用于MDD患者的疗效和安全性。该项目特别专注于既往经SSRI药物（包括礼来的Prozac、辉瑞的Zoloft、葛兰素史克的Paxil）治疗后，仅能获得部分缓解的重度抑郁症患者中未获满足的临床需求。这3项试验中，患者仍接受SSRI药物治疗，同时接受edivoxetine或安慰剂治疗。

礼来同时宣布，将不再推进edivoxetine的临床开发。

英文原文：Lilly depression drug fails late-stage trials

INDIANAPOLIS, Dec. 5, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that results from three studies of edivoxetine did not meet the primary study objective of superior efficacy in depression after eight weeks of treatment. When added to a selective serotonin reuptake inhibitor (SSRI), edivoxetine did not separate from placebo on the Montgomery-Asberg Depression Rating Scale (MADRS) in three acute randomized placebo-controlled Phase III studies (LNBM, LNBQ and LNBR).

While the safety and tolerability of edivoxetine was consistent with previous studies, the efficacy results do not support a regulatory submission for adjunctive treatment in patients with Major Depressive Disorder (MDD). Data from all three studies will be disclosed in appropriate scientific forums in 2014.

In 2010, Lilly launched the Phase III program for edivoxetine — a potent and highly selective norepinephrine reuptake inhibitor — to assess the benefits and risks of edivoxetine as an add-on therapy in patients with MDD.  The Phase III program specifically focused on meeting the unmet needs of patients with major depression who had achieved only a partial response to treatment with an SSRI.  In these three trials, patients remained on SSRI treatment and additionally received either edivoxetine or placebo.

"Lilly undertook a robust Phase III program to address a significant unmet need for people suffering from depression," said David Ricks, senior vice president, and president, Lilly Bio-Medicines. "However, the lack of efficacy compared to SSRI alone in three separate clinical trials means that Lilly will not proceed with development of edivoxetine as an add-on treatment for depression." The ongoing clinical study evaluating the long-term maintenance effect of edivoxetine will continue to completion.

"While disappointing for people suffering from depression, their families and Lilly, negative studies are unfortunately a reality of biopharmaceutical innovation, and are particularly prevalent in the area of neuroscience given the historically high placebo response rate," said Jan Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories. "Lilly remains committed to our neuroscience legacy of discovering and delivering innovative medicines, as evidenced by our pipeline of nine potential new medicines and diagnostic imaging agents for neuroscience-related diseases and disorders, including Alzheimer's disease, Parkinson's disease, depression, bipolar disorder, migraine prevention and osteoarthritis pain."

"Despite this news, we remain focused on implementing our innovation-based strategy," said Derica Rice, executive vice president, global services and chief financial officer, Eli Lilly and Company.  "We've made substantial progress on our number one priority - advancing our pipeline.  This year alone, we submitted four potential new medicines to regulatory authorities with more anticipated next year.  In addition, we expect to begin launching new products in 2014 and are on track to return to revenue growth and margin expansion in 2015 and beyond."

The decision not to proceed with development of edivoxetine as adjunctive treatment for MDD is expected to result in a fourth-quarter charge to R&D expense of approximately $15 million (pre-tax), or approximately $0.01 per share (after-tax). The company's previously-issued financial guidance for 2013 remains unchanged.