The Janssen Pharmaceutical Companies of Johnson & Johnson have 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 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. The most common treatment-emergent adverse events reported in the esketamine group were metallic taste, nausea, vertigo, dizziness, headache, drowsiness, short lived perceptual changes, blurred vision, paraesthesia (tingling sensation) and anxiety.
Data from a second study, in elderly patients aged 65 years and older with treatment-resistant depression, which is the first study of its kind in this population, 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. Safety results were consistent with previous studies of esketamine in younger adult populations. The most common treatment-emergent adverse events reported (>10% of patients) in the esketamine group were dizziness, nausea, headache, fatigue, increased blood pressure, vertigo and short lived perceptual changes. There were no treatment-emergent adverse events reported in >10% of patients in the placebo group.
Husseini K. Manji, MD, Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC said, “What makes this significant is that the response was rapid and this milestone was achieved in patients deemed to be treatment-resistant. We are also pleased with the clinically meaningful outcomes for esketamine nasal spray in elderly patients, a population that often has greater disability and lower response rates.”