Janssen Closes in on Seeking FDA Approval for Ketamine-Based Depression Treatment
Janssen Pharmaceuticals is eying a potential breakthrough in treating refractory major depressive disorder. The company plans to seek regulatory approval for its ketamine-based esketamine nasal spray this year and if given the green light it will be the first new approach for the indication in nearly 50 years.
On Friday the company unveiled Phase III results from two clinical studies in patients with treatment-resistant depression at the American Psychiatric Association Annual Meeting in New York. Study data shows that a combination of the flexibly dosed esketamine nasal spray and a newly initiated oral antidepressant demonstrated a “statistically significant, clinically meaningful rapid reduction of depressive symptoms as compared to placebo.” The first Phase III study included adults with treatment-resistant depression, which was defined as “patients who had not responded to two or more currently available antidepressants of adequate dose and duration in the current episode of depression.”
Calling it the first of its kind, Janssen’s second Phase III study was in the treatment of patients age 65 and up who have treatment-resistant depression. This study again combined esketamine with an oral antidepressant. Data showed that the combination demonstrated clinically meaningful effects compared to placebo, however, Janssen said the study narrowly missed statistical significance for its primary efficacy endpoint. Despite the narrow miss of the primary efficacy, Janssen said data results favored the esketamine nasal spray plus a newly initiated oral antidepressant group.
Husseini K. Manji, Global Head of Neuroscience Therapeutic Area at Janssen Research & Development, said approximately 30 percent of patients with major depression failing to respond to currently available antidepressants. Because of that failure rate, Manji said 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,” Manji said in a statement. “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.”
Major depressive disorder affects nearly 300 million people across the globe. The disorder negatively impacts quality of life and function in those people who are battling it.
Janssen’s esketamine nasal spray is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, which is also known as a glutamate receptor modulator. The therapy is thought to work by helping restore synaptic connections in brain cells in people with major depressive disorder. Esketamine received Breakthrough Therapy Designations from the U.S. Food and Drug Administration in November 2013 for treatment-resistant depression. It received the same designation in August 2016 for the indication of major depressive disorder with imminent risk for suicide.