Allergan’s NMDA drug rapastinel flops in phase 3 depression studies
Questex LLC | March 07, 2019
Rapastinel, the depression drug that Allergan picked up in its $560 million acquisition of Naurex, missed its primary endpoint in a trio of pivotal trials. What’s more, an interim analysis from a fourth study “suggests the primary and key secondary endpoints will not be met.” Allergan was testing the NMDA receptor modulator as an adjunct therapy in patients with major depressive disorder (MDD). In all, the three phases 3 studies enrolled 1,510 patients with MDD who had a partial response to antidepressant therapy. In two of the trials, patients received weekly injections of placebo or rapastinel on top of their oral antidepressants, the company said in a statement Wednesday afternoon. The third study was similar in design, except that it also evaluated a second, lower dose of rapastinel. The drug was well tolerated in all three of the studies but failed to differentiate from placebo on the primary and key secondary endpoints. "We are deeply disappointed with these results, and they are a vivid reminder that drug development is extremely challenging, especially in mental health,” said David Nicholson, Allergan’s R&D chief, in the statement.