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Depression Drug Fails Late-Stage Trials
Edivoxetine is equivalent to placebo (December 5)
According to an announcement from Eli Lilly, three randomized placebo-controlled phase III studies of their investigational depression drug edivoxetine did not meet the primary objective of superior efficacy compared with placebo after 8 weeks of treatment in patients with major depressive disorder (MDD).
When added to a selective serotonin reuptake inhibitor (SSRI), edivoxetine did not separate from placebo on the Montgomery–Asberg Depression Rating Scale (MADRS) in all three trials.
While the safety and tolerability of edivoxetine were consistent with that of previous studies, the efficacy results do not support a regulatory submission for adjunctive treatment in patients with MDD, the company says.
In 2010, Lilly launched the phase III program for edivoxetine — a highly selective norepinephrine reuptake inhibitor — to assess its benefits and risks as an add-on therapy in patients with MDD. The program focused on meeting the unmet needs of patients with MDD who had achieved only a partial response to treatment with an SSRI. In these three studies, the patients remained on SSRI treatment and also received either edivoxetine or placebo.
Source: Eli Lilly; December 5, 2013.