FDA recently granted Breakthrough Therapy Designation for esketamine (Janssen Research & Development), an investigational medication to treat major depressive disorder with imminent risk for suicide.
FDA recently granted breakthrough therapy designation for esketamine (Janssen Research & Development), an investigational medication to treat major depressive disorder with imminent risk for suicide.
Phase 2 trials have seen results with some patients responding to treatment within hours.
If approved by FDA, esketamine would be one of the first new approaches to treat major depressive disorder available to patients in the last 50 years. This also marks the second time esketamine has received a breakthrough therapy designation from FDA; the first was in November, 2013.
"In the U.S. alone, there are more than 41,000 suicides each year, many of which result from untreated or poorly-treated major depression," said Husseini K. Manji, MD, global head of the neuroscience therapeutic area for Janssen. "This designation reinforces the potential of esketamine as a novel treatment for patients with major depressive disorder who are at imminent risk for suicide, a condition for which there currently is no approved treatment and which represents a major public health challenge.”
Janssen Research & Development is currently conducting clinical trials to further evaluate the clinical benefit of esketamine and “looks forward to working closely with the FDA throughout the development and review process to bring this important potential new therapy to patients in critical need,” Manji said.
Esketamine for intranasal administration is a non-competitive and subtype non-selective activity-dependent N-methyl-D-aspartate (NMDA) receptor antagonist, which has a novel mechanism of action, meaning it works differently than currently available therapies for depression. The company is currently conducting phase 3 clinical trials for treatment-resistant depression.
Meanwhile, phase 2 clinical trial data for the drug was presented at the Society of Biological Psychiatry 71st Annual Scientific Meeting in Atlanta, in May. The phase 2a clinical study of esketamine demonstrated a clinically meaningful and statistically significant rapid reduction of depressive symptoms as compared to placebo (and standard of care) in patients with major depressive disorder who were at imminent risk for suicide.
The reduction in depressive symptoms was demonstrated by change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score, according to the company.
Intranasal esketamine was generally safe and well-tolerated, with an adverse event profile that was consistent with published data. “These results provide important evidence for the potential use of intranasal esketamine to treat patients with major depressive disorder and suicidal ideation, a condition for which there is an urgent public health need and currently no approved treatment,” Janssen said.