Lilly Announces Edivoxetine Did Not Meet Primary Endpoint of Phase III Clinical Studies as Add-On Therapy for Major Depressive Disorder
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
"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
"Despite this news, we remain focused on implementing our innovation-based strategy," said
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
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Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in
This press release contains forward-looking statements about edivoxetine and reflects Lilly's current beliefs. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. For further discussion of these and other risks and uncertainties, see Lilly's filings with the
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