Lilly’s depression drug fails to meet goal in phase 3

Eli Lilly and Company's edivoxetine did not meet its primary endpoint in phase 3 clinical trials as an add-on therapy for major depressive disorder.

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 three 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).

The phase three program, launched in 2010, specifically focuses on meeting the unmet needs of patients with major depression who had achieved only a partial response to treatment with an SSRI.

"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. 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."

Jan Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories.

"Despite this news, we remain focused on implementing our innovation-based strategy. 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."

Derica Rice, executive vice president, global services and chief financial officer, Eli Lilly and Company.

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). The company's previously-issued financial guidance for 2013 remains unchanged.

The ongoing clinical study evaluating the long-term maintenance effect of edivoxetine will continue to completion. Data from all three studies will be disclosed in appropriate scientific forums in 2014.