JnJ submits New Drug Application to USFDA for Spravato

New Delhi: The Janssen Pharmaceutical Companies of Johnson & Johnson(JnJ) recently announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking a new indication for SPRAVATO (esketamine) CIII nasal spray for the rapid reduction of depressive symptoms in adult patients with major depressive disorder (MDD) who have active suicidal ideation with intent.

The submission is based on results from the Phase 3 ASPIRE I & II trials, which evaluated the efficacy and safety of SPRAVATO versus placebo nasal spray in this high-risk patient population when used in addition to comprehensive standard of care (SOC). In these studies, comprehensive SOC included initial hospitalization and newly initiated and/or optimized antidepressant therapy.

“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,” said Husseini K. Manji, M.D., Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC. “It extends our focus on severe manifestations of the major depressive disorder beyond the current indication for treatment-resistant depression.”

The data from the ASPIRE I & II trials were recently presented at the 32nd European College of Neuropsychopharmacology (ECNP), which took place September 7-10 in Copenhagen, Denmark. The double-blind, randomized, placebo-controlled, multicenter studies both met their respective primary efficacy endpoint, which was a reduction in depressive symptoms at 24 hours after the first dose, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). In both studies, SPRAVATO 84 mg plus SOC showed clinically meaningful and statistically significant superiority (p=0.006) compared to placebo plus SOC in rapidly reducing symptoms of major depressive disorder. In these studies, comprehensive SOC included initial hospitalization and newly initiated and/or optimized antidepressant therapy.

The treatment difference between the two groups on the secondary endpoint of suicidality was not statistically significant. In the studies both SPRAVATO plus comprehensive SOC and placebo plus comprehensive SOC resulted in improvement in the severity of suicidality (a composite endpoint including suicidal ideation and behaviour) as measured by the revised Clinical Global Impression of Severity of Suicidality (CGI-SS-R) at 24 hours after the first dose. This may be due to the substantial beneficial effects of comprehensive SOC utilized in the clinical trial, including the immediate impact of inpatient psychiatric hospitalization in diffusing the acute suicidal crisis in patients in both treatment groups.

The FDA granted Breakthrough Therapy designation to esketamine nasal spray for major depressive disorder with imminent risk for suicide in August 20165 and approved SPRAVATO (esketamine) CIII nasal spray, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression in adults on March 5, 2019.

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