Esketamine receives Breakthrough Therapy Designation from FDA for major depressive disorder with imminent risk for suicide

Johnson & JohnsonJanssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for esketamine, an investigational antidepressant medication, for the indication of major depressive disorder with imminent risk for suicide. If approved by the FDA, esketamine would be one of the first new approaches to treat major depressive disorder available to patients in the last 50 years.

This also marks the second time esketamine has received a Breakthrough Therapy Designation from the U.S. regulatory authority. Esketamine was first granted this designation for treatment-resistant depression in November 2013. Breakthrough Therapy Designation is intended to expedite development and review timelines when preliminary clinical evidence indicates the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies for serious or life-threatening conditions.(1)

The esketamine Phase 2 clinical trial data presented by Janssen in May 2016 at the Society of Biological Psychiatry 71st Annual Scientific Meeting in Atlanta, Georgia, provided preliminary clinical evidence to support the Breakthrough Therapy Designation for major depressive disorder with imminent risk for suicide.(2)

"In the U.S. alone, there are more than 41,000 suicides each year,(3) 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."

About Esketamine
Esketamine for intranasal administration is an investigational compound being studied by Janssen as part of a global development program. Esketamine is a non-competitive and subtype non-selective activity-dependent N-methyl-D-aspartate (NMDA) receptor antagonist, which has a novel mechanism of action, meaning it works differently than currently available therapies for depression. The program in treatment-resistant depression is currently in Phase 3, with six ongoing clinical trials.

About Major Depressive Disorder
Major depressive disorder affects approximately 16 million people in the U.S.(4) and 121 million people worldwide. Individuals with depression, including major depressive disorder, experience continuous suffering from a serious, biologically based disease which can prevent them from enjoying life and functioning normally.(5) Depression is the psychiatric disorder most commonly associated with suicide.(6) In the U.S. alone, there are more than 41,000 suicides each year,(3) many of which result from untreated or poorly treated major depression. Only 30 percent of patients on currently available antidepressants achieve remission.(7) While conventional antidepressants can be effective in treating major depressive disorder, and thereby suicidal ideation, they are not FDA-approved for this use, and their delayed onset of effect, which takes three to six weeks, limits their value in treating acutely suicidal patients.

About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.

1. The U.S. Food and Drug Administration. "Expedited Programs for Serious Conditions." Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf. Accessed August 2016.
2. Canuso C, et al. "Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Subjects Assessed to be at Imminent Risk for Suicide." Society of Biological Psychiatry 71st Annual Scientific Meeting. May 12-14, 2016.
3. Centers for Disease Control and Prevention. National Center for Health Statistics. "Suicide and Self-inflicted Injury." Available at: http://www.cdc.gov/nchs/fastats/suicide.htm. Accessed August 2016.
4. National Institute of Mental Health. Major Depression Among Adults. Available at: http://www.nimh.nih.gov/health/statistics/prevalence/major-depression-among-adults.shtml. Accessed August 2016.
5. World Health Organization. Depression. Available at: http://www.who.int/mediacentre/factsheets/fs369/en/. Accessed August 2016.
6. American Association of Suicidology. Depression and Suicide Risk. Available at: http://www.suicidology.org/portals/14/docs/resources/factsheets/2011/depressionsuicide2014.pdf. Accessed August 2016.
7. National Institute of Mental Health. Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study. Available at: http://www.nimh.nih.gov/about/director/2011/antidepressants-a-complicated-picture.shtml#_edn2. Accessed August 2016.

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