Seltorexant, an investigational drug being developed by Johnson & Johnson, met all primary and secondary endpoints in a phase 3 trial of patients with major depressive disorder with insomnia symptoms, the company has announced.
The phase 3 MDD3001 study was a multicenter, randomized, double-blind trial comparing the efficacy and safety of 20-mg oral seltorexant once daily with placebo, added to background selective serotonin reuptake inhibitor/serotonin and norepinephrine reuptake inhibitor therapy, for improving depressive symptoms in adult and elderly patients with MDD with insomnia symptoms.
Consistent with previous trials of seltorexant, the drug was safe and well-tolerated, with similar rates of common adverse events seen in both treatment groups.
Source: Law Daily Report (lawdailyreport.net)
Sleep Disturbance Abnormal Sleep Pattern Sleep Disorder Somnipathy Major Depression Major Depressive Disorder Unipolar Depression Clinical Depression MDD Sleep Insomnia Sleeplessness Receptors Quality Of Life QOL Health Related Quality Of Life Health-Related Quality Of Life HRQOL Antidepressant Antidepressant Drug California Elderly/Concerns Of Older Adults Elderly
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