Eli Lilly will discontinue development of edivoxetine after it failed in late-stage trials as an add-on therapy for major depressive disorder.
The drug, a norepinephrine reuptake inhibitor, was evaluated in three Phase III trials in combination with selective serotonin reuptake inhibitors in MDD patients who had achieved only a partial response to treatment with the latter. In all of the studies, edivoxetine failed to show superior efficacy over placebo when used with SSRIs.
While the safety and tolerability of edivoxetine was consistent with previous studies, the efficacy results do not support a regulatory submission, Lilly noted. R&D chief Jan Lundberg said that “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”.
He added that “Lilly remains committed to our neuroscience legacy…as evidenced by our pipeline of nine potential new medicines and diagnostic imaging agents” for diseases, including Alzheimer’s, Parkinson’s disease, depression, bipolar disorder and migraine prevention.
The decision not to proceed with development of edivoxetine is expected to result in a fourth-quarter charge of about $15 million.
