Johnson & Johnson has announced that intransal esketamine being developed by its subsidiary Janssen Research & Development has received Breakthrough Therapy Designation from the FDA. According to J&J, the product is in Phase 3 development as a treatment for major depressive disorder with an imminent risk of suicide, and 6 clinical trials are currently underway.
Janssen presented data from the Phase 2 clinical program that was used to support the Breakthrough Therapy Designation at the Society of Biological Psychiatry Annual Scientific Meeting in May 2016.
Janssen Global Head, Neuroscience Therapeutic Area Husseini K. Manji commented, “In the US alone, there are more than 41,000 suicides each year, many of which result from untreated or poorly treated major depression. 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.”
In 2013, J&J revealed that it was developing the esketamine nasal spray. According to the company, the nasal spray also received breakthrough designaation that year.
Read the Johnson & Johnson press release.
