Johnson & Johnson seeks FDA approval for SPRAVATO in treatment-resistant depression

Johnson & Johnson (NYSE: JNJ) is seeking U.S. Food and Drug Administration (FDA) approval for SPRAVATO (esketamine) as a standalone treatment for adults with treatment-resistant depression (TRD). This application marks a significant milestone in the treatment of major depressive disorder (MDD).

The American pharma major has submitted a supplemental New Drug Application (sNDA) to the FDA, proposing SPRAVATO nasal spray as a monotherapy for adults struggling with treatment-resistant depression. This submission represents over a decade of research and clinical trials aimed at validating the safety and effectiveness of SPRAVATO. Currently, TRD affects nearly 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder. This condition is defined by a lack of response to at least two different oral antidepressants during a single depressive episode.

The sNDA is bolstered by data from the Phase 4 TRD4005 study, which assessed SPRAVATO’s efficacy, safety, and tolerability as a monotherapy. This randomized, double-blind, multicenter, placebo-controlled trial demonstrated significant improvement in depressive symptoms, with notable reductions in the Montgomery-Asberg Depression Rating Scale (MADRS) score observed as early as 24 hours after the first dose. These improvements were sustained for at least four weeks. The safety profile of SPRAVATO, when used alone, aligned with previously established data from studies where it was combined with oral antidepressants, showing no new safety concerns.

SPRAVATO has been previously approved by the FDA in conjunction with an oral antidepressant for adults with TRD and depressive symptoms accompanied by acute suicidal ideation or behavior. The drug has been sanctioned in 77 countries and has been administered to over 100,000 patients globally. Johnson & Johnson’s recent application aims to expand SPRAVATO’s use by offering it as a monotherapy, potentially transforming treatment options for individuals with difficult-to-treat depression.

The push for SPRAVATO monotherapy approval underscores a growing recognition of the need for effective treatments for those who do not respond to conventional therapies. As Bill Martin, PhD, Global Therapeutic Area Head for Neuroscience at Johnson & Johnson Innovative Medicine, noted, many patients face prolonged periods of ineffective treatment, causing significant emotional and functional burdens. By advancing SPRAVATO’s approval, Johnson & Johnson aims to alleviate this burden and offer a promising new option for those in urgent need.