Eli Lilly and Company (LLY) on Thursday said it would not seek approval for edivoxetine, an experimental drug to treat major depression, after it failed to meet its primary endpoint in three late-stage trials.
LY2216684 (edivoxetine) was designed to inhibit the reuptake of norepinephrine. It was being studied as an add-on therapy for major depressive disorder and as a monotherapy for pediatric attention deficit hyperactivity disorder (ADHD). The setback is a disappointment as LLY has had long success in the market for psychiatric drugs, especially because the setback leaves Lilly without any new psychiatric drugs in its late-stage pipeline. The most advanced depression drug in LLY’s pipeline is LY2940094, a NOC-1 antagonist, currently in phase 2 trials.
Lilly lost patent protection for its largest-selling drug, Zyprexa, an atypical antipsychotic in 2012, and sales dropped over 80%. That left Cymbalta, a seratonin-norepinephrine reuptake inhibitor (SNRI) for depression, as Lilly’s best-selling drug, with just over $5 billion in sales. Cymbalta’s primary competition in the depression market is Pfizer’s now-generic Effexor, the first drug in the SNRI class. The primary benefit of Cymbalta over Effexor was that it did not require patients to titrate (slowly increase dosages) to get to a therapeutic dose; however, Cymbalta never really succeeded as a depression drug. A significant portion of Cymbalta prescriptions are for nerve pain (neuropathy).
The failure is another setback for new depression drugs which have generally failed to find a new mechanism since the introduction of the SNRI’s in 1993. Vilbryd, made by Forest Lab’s (FRX) and introduced in 2011, is the last new depression drug introduced into the U.S. Vilbryd, however, carries a black box warning and has not been highly successful, with annual sales of less than $200 million.
