The Janssen Pharmaceutical Companies of Johnson & Johnson announced the results from two Phase 3 clinical studies of the investigational compound esketamine nasal spray in patients with treatment-resistant depression. Data from a study in adults with treatment-resistant depression showed that flexibly dosed esketamine nasal spray plus a newly initiated oral antidepressant demonstrated a statistically significant, clinically meaningful rapid reduction of depressive symptoms as compared to placebo nasal spray plus a newly initiated oral antidepressant. The study defined treatment-resistant as patients who had not responded to two or more currently available antidepressants of adequate dose and duration in the current episode of depression. Data from a second study, in elderly patients aged 65 and older with treatment-resistant depression, which is the first study of its kind, showed treatment with flexibly dosed esketamine plus a newly initiated oral antidepressant demonstrated clinically meaningful effects compared to placebo nasal spray plus a newly initiated oral antidepressant. However, the study narrowly missed statistical significance for its primary efficacy endpoint. If approved by the U.S. Food and Drug Administration, esketamine would be one of the first new approaches to treat refractory major depressive disorder available to patients in the last 50 years. These findings represent two of the five Phase 3 studies that comprise Janssen’s treatment-resistant depression program with esketamine nasal spray. The results from these studies will inform regulatory filings for esketamine nasal spray in treatment-resistant depression, for which Janssen has received Breakthrough Therapy Designations from the U.S. FDA. Data from other Phase 3 studies will be presented later in 2018.
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