SPRAVATO® Approved as First and Only Monotherapy for Treatment Resistant Depression in the U.S.

Published: 23 Jan 2025

Author: Precedence Research

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Johnson & Johnson recently received a supplemental New Drug Application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray; thus, becoming the first and only monotherapy for the treatment of adults diagnosed with treatment-resistant depression (TRD) who remain unboosted concerning oral antidepressants. This condition, on the other hand, affects an estimated 21 million Americans, with one-third receiving poor responses to oral antidepressants either exclusively or additionally.

Furthermore, SPRAVATO® has a novel approach in that it offers relief from symptoms within 24 hours and lasting improvement by the 28th day without needing to take oral antidepressants every day. The approval comes after a recent double-blind, multicenter, placebo-controlled, and randomized study, which found that patients could expect a significant change within as early as 24 hours following the initial SPRAVATO® dose. The rapid symptom improvement was outweighed by dramatic four-week efficacy, with a significant change in all 10 categories of the Montgomery-Asberg Depression Rating Scale (MADRS) by Day 28. There were no new safety concerns when the drug was used as monotherapy.

Personalizing Treatment Plans

Grégory Mattingly, the president of Midwest Research Group, said SPRAVATO® would entrench its potential as a breakthrough treatment for TRD with already over 140,000 patients treated worldwide right after its first approval. It has been administered to treat patients globally and is transforming the treatment landscape. In comparison to other potential agents for TRD such as when such patients have already failed two antidepressants, at least 86 of these people still turn out to have failed remission. Moreover, half of the economic burden of depression comes from TRD alone. A very important alternative for patients is those who, because of troublesome traditional treatments, have not really responded to any of these treatments. Exclusively available through the REMS system such as Risk Evaluation and Mitigation Strategy.

Global Reach and Future Potential

SPRAVATO® launched in 77 nations, joins the global effort to upgrade mental health care. A remarkable decade of investigative observation and six years of application brought about genuinely significant changes for those 15, and 16 with TRD. Another crucial moment in history is the FDA's approval of SPRAVATO® as the first stand-alone treatment for TRD. The faster and more significant reduction in symptoms 16 and 17 compared to LF and placebo involves a completely different level of study. In contradistinction, SPRAVATO® addresses important substantive gaps in the current treatment environment by acting and delivering efficacy in 1/2-1 day and throughout the next 28 days. SPRAVATO® might give hope on its own to millions worldwide who have TRD; something that is hopeful about every individual is its unique mode of action, targeting GLUTAMATE pathways and also being well established and proven in clinical safety. Evidence hailing from around the globe has corroborated evidence supporting SPRAVATO® and attesting to its reality as a strong hand used not just in the battle against depression.