Mixed data for J&J's antidepressant in Phase III trials

The Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ) reported mixed data from two Phase III trials testing intranasal esketamine (formerly JNJ-54135419) in patients with treatment-resistant depression. The NMDA receptor antagonist met the primary endpoint in the TRANSFORM-2 trial, but missed TRANSFORM-3's primary endpoint.

In both trials, the primary endpoint measured change from baseline to week four in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. In TRANSFORM-2, esketamine significantly improved least squares mean difference vs. placebo (-4.0, 95% CI: -7.31, -0.64, one-sided p=0.01). In TRANSFORM-3, it failed to do so (-3.6, 95% CI: -7.2, 0.07, one-sided p=0.029). The company defined significance as a one-sided p-value of 0.025...