J&J Unit: Esketamine Study Didn't Show Statistical Significance for Primary Endpoint

   By Josh Beckerman

Johnson & Johnson's (JNJ) Janssen Pharmaceutical Cos. unit said a Phase 3 study of its esketamine nasal spray with patients who have treatment-resistant depression didn't demonstrate statistical significance for its primary endpoint.

The company said "results of analyses of the primary endpoint and key secondary endpoints numerically favored both esketamine plus oral antidepressant treatment groups over the oral antidepressant plus placebo group."

The clinical trial was one of five pivotal Phase 3 studies of the product. Janssen said that "together with the recently announced results from four other Phase 3 studies, these data provide continued support for a positive benefit-risk assessment for esketamine nasal spray as a potentially novel treatment approach for patients living with treatment-resistant depression."

On Sept. 4, the company said it filed a new drug application with the U.S. Food and Drug Administration for esketamine.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

September 21, 2018 20:05 ET (00:05 GMT)

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