The Titusville, N.J.-based company said that if approved by the FDA, esketamine would represent one of the first new approaches designed to treat refractory major depressive disorder in the last 50 years.
In a study of adults with treatment-resistant depression, Janssen found that flexibly-dosed esketamine nasal spray plus a newly-initiated oral antidepressant resulted in a statistically significant reduction of symptoms compared to a placebo spray combined with a newly-initiated oral antidepressant.
In a second study, patients ages 65 and older with treatment-resistant depression experienced a clinically meaningful reduction of symptoms with the nasal spray-oral drug combination compared to patients taking a placebo-oral drug combination. But Janssen noted that the difference was not statistically significant and the trial missed its primary endpoint.
“With about 30% of patients with major depression failing to respond to currently available antidepressants, treatment-resistant depression represents a major public health need,” Dr. Husseini Manji, global head of the neuroscience therapeutic area in Janssen’s R&D unit, said in prepared remarks.
“The positive Phase III 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,” Manji added.
“There’s a critical need for new, rapidly acting and effective treatment options for people with major depressive disorder who do not respond to existing therapies,” Dr. Mathai Mammen, global head of R&D at Janssen, said. “Janssen is fully committed to exploring the newest science in the area of mood disorders and bringing these discoveries to patients in need.”