Major Depressive Disorder Treatment Granted Breakthrough Therapy Designation

Janssen Research & Development, LLC, a Johnson & Johnson company, recently announced that the FDA granted Breakthrough Therapy Designation to its experimental antidepressant.

The drug, esketamine, received the new designation for the treatment of patients with major depressive disorder who have an imminent suicide risk. According to a press release from Johnson & Johnson, if it received FDA-approval, it would be among the only new approaches to treat major depressive disorder in the past 50 years.

Esketamine originally received a Breakthrough Therapy Designation from the FDA in 2013 for treatment-resistant depression. There are currently six phase 3 trials being conducted relating to this designation.

Results from a phase 2 clinical trial were recently presented at a conference that provided preliminary evidence to support the new designation.

The intranasal treatment is a non-competitive, and subtype non-selective activity-dependent N-methyl-D-aspartate receptor aspartate receptor antagonist that works differently than any other available antidepressants currently available, according to the press release.

“In the US 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, Neuroscience Therapeutic Area, 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.

"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.”