Janssen has announced the submission of a Type II Variation Application to the European Medicines Agency (EMA) for its major depressive disorder (MDD) treatment, Spravato (esketamine).
The application, which is based on two Phase III clinical studies (ASPIRE I & II) which evaluated both the efficacy and safety of the drug, seeks to expand the use to adults with MDD who have current suicidal ideation with intent.
In the studies, Spravato was added to current standard of care, which included initial hospitalisation and newly initiated and/or optimised antidepressant therapy, enhanced with extensive twice-weekly visits during the double-blind phase.
Data from the trials showed that when combined with the standard of care, the nasal spray was associated with a reduction in depressive symptoms, and demonstrated clinically meaningful and statistically significant superiority over a placebo in rapidly reducing symptoms of MDD at 24 hours.
Husseini K. Manji, global head, neuroscience therapeutic area said: “There is a need to provide treatments that can rapidly reduce depressive symptoms of individuals living with MDD who are in need of urgent relief.
We therefore look forward to working with the EMA to provide a new targeted treatment that could potentially deliver meaningful results for these patients.”
In October 2019, a supplemental New Drug Application was also submitted to the US Food and Drug Administration (FDA) for the treatment in the same indication.
Last December, Spravato was approved by the European Commission for use in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), in adult patients with treatment-resistant major depressive disorder.