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Lilly Announces Edivoxetine Did Not Meet Primary Endpoint of Phase III Clinical Studies as Add-On Therapy for Major Depressive Disorder
Date:12/5/2013

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 continu
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