New, Data

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive results from two pivotal Phase 3 clinical studies (ASPIRE I & II) to evaluate the efficacy and safety of esketamine nasal spray in addition to comprehensive standard of care (SOC) in adult patients with major depressive disorder who have active suicidal ideation with intent.

09.09.2019 - 15:19:24

New Data from Esketamine Nasal Spray Phase 3 Studies Showed Rapid Reduction of Depressive Symptoms in Adult Patients with Major Depressive Disorder Who Have Active Suicidal Ideation with Intent. These studies were presented at the 32nd European College of Neuropsychopharmacology (ECNP), taking place September 7–10 in Copenhagen.

or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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[i] Fu DJ, et al. Esketamine nasal spray for rapid reduction of major depressive disorder symptoms in patients at imminent risk for suicide. ASPIRE-1 study. Poster P323 presented at ECNP 2019, 7–10 September, Copenhagen, Denmark.
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[x] Johnson & Johnson Ltd. Press Release August 2016. Esketamine Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Major Depressive Disorder with Imminent Risk for Suicide. Available at: https://www.jnj.com/media-center/press-releases/esketamine-recieves-breakthrough-therapy-designation-from-us-food-and-drug-administration-for-major-depressive-disorder-with-imminent-risk-of-suicide. (last accessed September 2019).
[xi] Johnson & Johnson Ltd. Press release October 2018. Janssen Submits European Marketing Authorisation Application for Esketamine Nasal Spray for Treatment-Resistant Depression. Available at: https://www.jnj.com/janssen-submits-european-marketing-authorisation-application-for-esketamine-nasal-spray-for-treatment-resistant-depression. (last accessed September 2019).
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