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The company received breakthrough therapy designation for esketamine, a treatment for major depressive disorder with imminent risk for suicide.
On August 16, 2016, FDA granted breakthrough therapy designation to Johnson & Johnson subsidiary, Janssen Research & Development, for the company’s investigational antidepressant medication, esketamine. Esketamine was granted breakthrough therapy designation for the treatment of major depressive disorder with imminent risk for suicide. This is the second time esketamine has received breakthrough therapy designation, the drug received this distinction for treatment-resistant depression in November 2013.
"In the US 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, Neuroscience Therapeutic Area, Janssen said in a press announcement. "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."
Source: Johnson & Johnson