Janssen submits Spravato's expansion in the EU

johnson has announced that it will submit to the European Medicines Agency (EMA) the treatment drug Spravato (esketamine), which is variant II of its main form of severe depression (MDD).The application was based on two phase iii clinical studies (aspire i and ii) that assessed the efficacy and safety of the drug and aimed at extending its use to adult patients with severe depression who currently have suicidal intentions.In the study, spravato was added to current standards of care, including initial hospitalization and newly initiated and/or optimized antidepressant therapy, with extensive visits twice a week during the double-blind phase.Data from the trial showed that, when combined with standard care, nasal sprays reduced depressive symptoms and showed better clinical and statistical significance than placebos in rapidly reducing symptoms of severe depression within 24 hours.Husseini K. Manji, global head of neuroscience therapy, said: "There is a need to provide treatments that can rapidly alleviate depressive symptoms in patients with severe depression who need urgent remission.Therefore, we look forward to working with the EMA to provide a new targeted treatment that will deliver meaningful results for these patients. In2019, applications for new supplements for treatments with the same adaptive disorders were also submitted to the U.S. Food and Drug Administration.In December, Spravato was approved by the European Commission to be used in a joint use with selective 5-serotonin reuptake inhibitors (ssri) or 5-serotonin and epinephrine reuptake inhibitors (snri) for adult patients with drug-resistant severe depression. （cyy123.com）