FDA grants breakthrough therapy designation to anti-depressant medication Esketamine

16 August 2016 (Last Updated August 16th, 2016 18:30)

Johnson & Johnson subsidiary Janssen Research & Development’s investigational anti-depressant medication, Esketamine, has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) to treat major depressive disorder with an imminent risk for suicide.

Johnson & Johnson subsidiary Janssen Research & Development’s investigational anti-depressant medication, Esketamine, has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) to treat major depressive disorder with an imminent risk for suicide.

Esketamine, for intranasal administration, is a non-competitive and subtype non-selective, activity-dependent, N-methyl-D-aspartate (NMDA) receptor antagonist.

The compound is being studied by Janssen as part of a global development programme in treatment-resistant depression, and is currently in Phase III with six ongoing clinical trials.

Janssen neuroscience therapeutic area global head Dr Husseini K. Manji said: "In the US alone, there are more than 41,000 suicides each year, many of which result from untreated or poorly treated major depression.

"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."

Esketamine was granted this second Breakthrough Therapy Designation for major depressive disorder with an imminent risk for suicide based on Phase II clinical trial data.

In November 2013, the medication was first granted this designation for treatment-resistant depression.

Depression is a psychiatric disorder most commonly associated with suicide. More than 41,000 suicides are recorded in the US alone on an annual basis.

About 121 million people worldwide are affected with major depressive disorder, while approximately 16 million people are affected in the US alone.