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ARTICLE | Clinical News

J&J reports mixed Phase III data of esketamine for depression

May 11, 2018 5:27 PM UTC

The Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ) reported mixed data from two double-blind, international Phase III trials evaluating intranasal esketamine (formerly JNJ-54135419) to treat 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 the change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at week four. In TRANSFORM-2, esketamine led to a significant placebo-adjusted mean improvement on the endpoint of 4 points (one-sided p=0.01). In TRANSFORM-3, esketamine led to a non-significant placebo-adjusted mean improvement on the endpoint of 3.6 points (one-sided p=0.029). The threshold for significance in both trials was a one-sided p-value of ≤0.025...

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Johnson & Johnson

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NMDA receptor