Posted by Michael Wonder on 16 Jan 2020
Janssen seeks expanded use of Spravato (esketamine) nasal spray in Europe as a treatment for depressive symptoms in adults with major depressive disorder who have current suicidal ideation with intent
15 January 2020 - In two pivotal Phase 3 trials, Spravato combined with comprehensive standard of care achieved statistically significant rapid reduction of depressive symptoms in patients with major depressive disorder who have current suicidal ideation with intent compared to comprehensive standard of care alone.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II Variation Application to the EMA for Spravato (esketamine) nasal spray. The application seeks to expand the use of esketamine nasal spray, beyond its current indication, as an acute short-term treatment, co-administered with oral antidepressant therapy, for the rapid reduction of depressive symptoms in adults with a moderate-to-severe depressive episode of major depressive disorder who have current suicidal ideation with intent.
The submission is based on results from two double-blind, randomised, placebo-controlled multi-centre Phase 3 clinical studies (ASPIRE I & II), which evaluated both the efficacy and safety of esketamine nasal spray versus a placebo nasal spray when used in addition to comprehensive standard of care.
