The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) seeking a new indication for SPRAVATO® (esketamine) CIII nasal spray for the rapid reduction of depressive symptoms in adult consumers with major depressive disorder (MDD) who have active suicidal ideation with intent. The submission is based on results from the Phase 3 ASPIRE I & II trials, which evaluated the efficacy and safety of SPRAVATO® versus placebo nasal spray in this high-risk population when used in addition to comprehensive standard of care (SOC). In these studies, comprehensive SOC included initial hospitalization and newly initiated and/or optimized antidepressant therapy.
The data from the ASPIRE I & II trials were recently presented at the 32nd European College of Neuropsychopharmacology (ECNP), which took place September 2019 in Copenhagen, Denmark. The double-blind, randomized, placebo-controlled, multicenter studies both met their respective primary efficacy endpoint, which was a reduction in depressive symptoms at 24 hours after the first dose, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). In both studies, SPRAVATO® 84 mg plus SOC showed clinically meaningful and statistically significant superiority compared to placebo plus SOC in rapidly reducing symptoms of major depressive disorder. In these studies, comprehensive SOC included initial hospitalization and newly initiated and/or optimized antidepressant therapy.
The FDA granted Breakthrough Therapy designation to esketamine nasal spray for MDD with imminent risk for suicide in August 2016 and approved SPRAVATO® (esketamine) CIII nasal spray, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression in adults on March 5, 2019. MDD affects nearly 300 million people of all ages globally and is the leading cause of disability worldwide. With approximately 17 million adults diagnosed in the U.S., people with MDD experience suffering that has a significant negative impact on all aspects of life, including quality of life and function.
Janssen seeks to create a future where disease is a thing of the past. As the Pharmaceutical Companies of Johnson & Johnson, the company is working tirelessly to make that future a reality for consumers everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. Janssen focuses on areas of medicine where the company can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
This was reported by Janssen Pharmaceutical Companies of Johnson & Johnson on October 2, 2019.
Contact information: Stela Meirelles, Senior Director, Global Communications & Public Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, 1000 U.S. Route 202 South, Raritan, New Jersey 08869; 732-258-1540; Website: www.janssen.com