Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to gain approval for SPRAVATO® (esketamine) CIII nasal spray as a monotherapy for adults with treatment-resistant depression (TRD). Approximately 30% of the 280 million individuals worldwide with major depressive disorder (MDD) have TRD, characterized by an inadequate response to two or more oral antidepressants during the same depressive episode.

Bill Martin, PhD, Global Therapeutic Area Head of Neuroscience at Johnson & Johnson Innovative Medicine, remarked, “Patients with hard-to-treat depression often endure prolonged periods trying ineffective treatments, leading to significant emotional and functional challenges. We are eager to build on over a decade of research that supports SPRAVATO®’s safety and efficacy, and we look forward to collaborating with the FDA to offer this new monotherapy option.”

The sNDA is supported by favorable results from the Phase 4 TRD4005 study, which evaluated SPRAVATO® as a standalone therapy. This randomized, double-blind, multicenter, placebo-controlled trial revealed a rapid improvement in Montgomery-Asberg Depression Rating Scale (MADRS) scores as early as 24 hours after the initial dose of SPRAVATO®, with benefits sustained for at least four weeks. The safety profile of SPRAVATO® as a monotherapy aligns with previous findings when used in combination with an oral antidepressant, with no new safety concerns identified.

Currently, SPRAVATO® is approved by the FDA in combination with an oral antidepressant for treating adults with TRD and depressive symptoms in MDD with acute suicidal ideation or behavior. The treatment is available in 77 countries and has been administered to more than 100,000 people globally.

SPRAVATO® is not intended for pain relief or as an anesthetic, and its effectiveness for preventing or alleviating suicidal thoughts has not been confirmed. It should not replace hospitalization if deemed necessary by your healthcare provider, even if symptoms improve after the first dose. The safety and efficacy of SPRAVATO® in children have not been established.
 

 

Source: prnewswire.com

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