Janssen Pharmaceutical has announced that data from a Phase 3 study demonstrated significantly significant and clinically meaningful reduction of symptoms in adult patients with treatment-resistant depression who received esketamine nasal spray plus an oral antidepressant compared to those who received placebo plus an oral antidepressant. A second study in patients aged 65 and older demonstrated clinically meaningful but not statistically significant reduction of symptoms.
Both studies used flexible dosing, with adult patients receiving either 56 mg or 84 mg of esketamine plus a newly initiated oral antidepressant and the geriatric patients receiving either 28, 56, or 84 mg plus newly initiated oral antidepressant. The primary endpoint was change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at day 28.
Results from 3 other Phase 3 studies of the esketamine nasal spray are expected later this year. Intranasal esketamine received Breakthrough Therapy designation from the FDA in 2016. Data from a Phase 2 study of the nasal spray were published in JAMA Psychiatry in December 2017.
Janssen Research & Development Global Head, Neuroscience Therapeutic Area, Husseini K. Manji commented, “With about 30 percent of patients with major depression failing to respond to currently available antidepressants, treatment-resistant depression represents a major public health need. The positive Phase 3 results for esketamine nasal spray in adults with treatment-resistant depression are exciting, particularly as they mark the first time an antidepressant has achieved superiority versus an active comparator in any clinical trial for major depressive disorder. What makes this even more 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.”
Read the Johnson & Johnson press release.
