Janssen obtains FDA blessing for new indication for Spravato
Patients with major depressive disorder, or MDD, have a new medication to treat their condition.
The Food and Drug Administration has given Janssen clearance for a new indication for Spravato (esketamine) nasal spray. The medication, when taken with an oral antidepressant, is used to treat depressive symptoms in adults with MDD with acute suicidal ideation or behavior.
Spravato is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours, providing a new option for significant symptom relief until a longer-term, comprehensive treatment plan can take effect, the company said.
"It is astonishing to me that despite what we know about the risk of serious suicidal ideation in the context of major depression, patients with suicidal ideation have previously been excluded from nearly all studies examining antidepressant treatment efficacy. There is an immense need for high-quality evidence showing effective and rapid antidepressant action in this population," said Gerard Sanacora, director, Yale Depression Research Program, co-director, Yale-New Haven Hospital Interventional Psychiatry Service, and esketamine clinical trial investigator. "The clinical trials supporting this new indication provide compelling evidence that esketamine may offer clinicians a new way to provide support to patients quickly in the midst of an urgent depressive episode and help set them on the path to remission."
With this new indication, Spravato can be prescribed to treat depressive symptoms in two MDD subpopulations of adults with high unmet need: treatment-resistant depression, which the FDA approved on March 5, 2019, and MDD with acute suicidal ideation or behavior.
"People living with major depression need more options to meet their most critical needs, and we're proud to help redefine how we treat ongoing and acutely worsening depressive symptoms," said Bill Martin, global therapeutic area head, Neuroscience, Janssen Research & Development. "Spravato can now help patients with challenging to treat depression find significant and swift relief from debilitating depressive symptoms, offering those living with this serious mental health condition the possibility of a better future."