Posted by Michael Wonder on 03 Oct 2019
Janssen submits supplemental new drug application to U.S. FDA for Spravato (esketamine) CIII nasal spray for the rapid reduction of depressive symptoms in adults with major depressive disorder who have active suicidal ideation with intent
2 October 2019 - If approved, Spravato would be the first treatment for this severely ill population who historically have been excluded from anti-depressant clinical trials.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental new drug application to the U.S. FDA seeking a new indication for Spravato (esketamine) CIII nasal spray for the rapid reduction of depressive symptoms in adult patients with major depressive disorder 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 patient population when used in addition to comprehensive standard of care (SOC). In these studies, comprehensive SOC included initial hospitalisation and newly initiated and/or optimised antidepressant therapy.
