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FDA grants Breakthrough Therapy Designation to esketamine for MDD, imminent suicide risk

Janssen recently announced that the FDA granted a Breakthrough Therapy Designation for esketamine, a non-competitive and subtype non-selective activity-dependent N-methyl-D-aspartate receptor antagonist, for major depressive disorder and imminent risk for suicide.

Esketamine received this designation for treatment-resistant depression in November 2013.

Husseini K. Manji

Phase 2 study results presented in May 2016 indicated preliminary clinical evidence to support the designation for major depressive disorder with imminent risk for suicide.

“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,” Husseini K. Manji, MD, global head of neuroscience therapeutic area at Janssen, said in a press release. “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. We are currently conducting clinical trials to further evaluate the clinical benefit of esketamine and look 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.”