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Lilly Depression Treatment Fails Trial

Edivoxetine shows no benefit in MDD when added to SSRI

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Eli Lilly and Co. posted results from three studies of edivoxetine. The treatment 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.

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 will not proceed with development of edivoxetine as an add-on treatment for depression. However, the ongoing study evaluating the long-term maintenance effect of edivoxetine will continue to completion.

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