Johnson & Johnson announced the submission of a Type II Variation Application to the European Medicines Agency (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 (MDD) who have current suicidal ideation with intent. The submission is based on results from two double-blind, randomised, placebo-controlled multicentre Phase 3 clinical studies (ASPIRE I & II), which evaluated both the efficacy and safety of esketamine nasal sprayversus a placebo nasal spray when used in addition to comprehensive standard of care (SOC). In these studies, SOC included initial hospitalisation and newly initiated and/or optimised antidepressant therapy, enhanced with extensive twice-weekly visits during the double-blind phase. In both ASPIRE I & II, esketamine nasal spray combined with comprehensive SOC was associated with a reduction in depressive symptoms, and demonstrated clinically meaningful and statistically significant superiority over a placebo nasal spray plus comprehensive SOC in rapidly reducing symptoms of MDD at 24 hours after the first dose. The benefit of esketamine nasal spray plus comprehensive SOC on symptoms of MDD was apparent as early as 4 hours after the first dose.