Forest Laboratories and Pierre Fabre yesterday revealed that their investigational depression drug, levomilnacipran, was no better than placebo in a late-stage trial to treat major depressive disorder.
However, the companies appeared upbeat, saying levomilnacipran “consistently” showed improvement over placebo despite the results failing to reach statistical significance. They also point to an earlier Phase II study, which did demonstrate a significant improvement of the levomilnacipran group over placebo receivers.
Forest and Pierre Fabre say two additional Phase III studies of the serotonin and noradrenaline reuptake inhibitor in MDD are underway, with results expected to be made available in the second half of the year.
MDD affects around 18 million people in the USA alone, costing the country’s healthcare system in the region of $44 billion every year. The World Health Organisation predicts depression will become the leading cause of disability by the year 2020.