Spravato (esketamine) is submitted to the FDA as the first and only monotherapy for adults with treatment-resistant depression – Johnson & Johnson

Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking approval of Spravato (esketamine) CIII nasal spray as a monotherapy for adults living with treatment-resistant depression (TRD). Nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder (MDD) 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, PhD, 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.”

The submission Spravato supported by positive results from the Phase IV 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 4 weeks of treatment. 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.

Spravato is approved by the FDA, in combination with an oral antidepressant, to treat adults with TRD and depressive symptoms in adults with MDD with acute suicidal ideation or behavior. To date, Spravato has been approved in 77 countries and administered to more than 100,000 people worldwide.