Despite safety signals, esketamine nears rare approval in depression

1 June 2018
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The Johnson & Johnson (NYSE: JNJ) unit Janssen appears to have one of the hottest prospects in neuroscience on its hands in the shape of esketamine, but that it not to say it is proving immune to encountering the challenges of this tricky therapy area.

While a nasal spray formulation of the drug showed impressive efficacy results in two long-term Phase III clinical studies in treatment-resistant depression (TRD), there were some notable issues on the safety side.

These studies, one that showed a delayed time to relapse and a second that provided evidence of safe long-term use of esketamine, were presented at the Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP) in Florida on Thursday.

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