Janssen Pharmaceutical said that it has submitted a supplemental new drug application to the FDA requesting to expand the use of Spravato esketamine CIII nasal spray for the treatment of major depressive disorder in patients with active suicidal ideation with intent. The company recently published positive results from the Phase 3 ASPIRE 1 and 2 studies of Spravato plus standard of care versus placebo for this indication.
In August 2016, Spravato was granted Breakthrough Therapy designation for major depressive disorder with imminent risk for suicide. The nasal spray was approved by the FDA in March 2019 for the treatment of treatment-resistant depression. Distribution of Spravato is restricted under a Risk Evaluation and Mitigation Strategy (REMS).
Janssen Research & Development Global Head, Neuroscience Therapeutic Area, Husseini K. Manji said, “This submission is a significant step in helping a vulnerable patient population by providing a potential treatment option to rapidly reduce symptoms of depression in adults with active suicidal ideation with intent, which constitutes a psychiatric emergency that requires immediate intervention. It extends our focus on severe manifestations of major depressive disorder beyond the current indication for treatment-resistant depression.”
Read the Janssen press release.
