Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has submitted a Type II variation application to the European Medicines Agency (EMA) for the expanded indication of its SPRAVATO (esketamine) nasal spray.
The company seeks expanded indication for its nasal spray, co-administered with oral antidepressant therapy, as a short-term treatment for the reduction of depressive symptoms in adults with a depressive episode of major depressive disorder (MDD) with intentional suicidal ideation.
Janssen research & development neuroscience therapeutic area global head Husseini Manji said: “Janssen is committed to reducing the devastating burden caused by serious mental health disorders. 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.”
EC and the US FDA approved SPRAVATO nasal spray for TRD in 2019
SPRAVATO nasal spray is said to work against the N-methyl-D-aspartate (NMDA) glutamate receptor and was designed to provide a new mechanism of action to treat MDD.
The SPRAVATO facilitates self-administration through a single-use nasal spray device and offers a new method of drug administration for the treatment of MDD.
Janssen said that its regulatory submission is based on results from Phase 3 ASPIRE I & II clinical trials, which evaluated the efficacy and safety of the SPRAVATO nasal spray, compared to a placebo nasal spray, in addition to the standard of care (SOC).
The company has secured the European Commission approval of SPRAVATO nasal spray, in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), for treatment-resistant major depressive disorder (TRD), in December 2019.
In March 2019, the US Food and Drug Administration (FDA) has approved esketamine, in combination with an oral antidepressant, for TRD patients.
In October 2019, the company has submitted a supplemental New Drug Application (NDA) to the US FDA for its SPRAVATO nasal spray, for the reduction of depressive symptoms in MDD patients with intentional suicidal ideation.
