Currently, Spravato is approved by the FDA in combination with an oral antidepressant.
Johnson & Johnson said it has submitted a supplemental new-drug application to the U.S. Food and Drug Administration for approval of Spravato (esketamine) CIII nasal spray as a monotherapy for adults living with treatment-resistant depression (TRD).
The submission comes on the heels of positive results from the Phase 4 TRD4005 study that evaluated the efficacy, safety and tolerability of Spravato administered as a monotherapy.
The randomized, double-blind, multicenter placebo-controlled study showed a rapid change in Montgomery-Asberg Depression Rating Scale (MADRS) total score as early as 24 hours after the first Spravato dose and sustained through at least four weeks of treatment, according to Johnson & Johnson. The safety profile of Spravato monotherapy was consistent with the existing body of clinical data in combination with an oral antidepressant, and no new safety concerns were identified, the company noted.
Currently, Spravato is approved by the FDA, in combination with an oral antidepressant, to treat adults with TRD and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior.
According to data cited by Johnson & Johnson, nearly 30% of the estimated 280 million people worldwide living with major depressive disorder have TRD, which occurs when there is an inadequate response to two or more oral antidepressants during the same depressive episode.
“Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” said Bill Martin, global therapeutic area head, neuroscience, Johnson & Johnson Innovative Medicine. “We’re pleased to build on the more than a decade of research reinforcing the safety and efficacy of Spravato and look forward to working with the FDA to bring this innovative treatment to patients as a monotherapy option.”
To date, Spravato has been approved in 77 countries and administered to more than 100,000 people worldwide, according to the company.