FDA approved SPRAVATO® (esketamine) in the U.S. as the first and only monotherapy for adults with treatment-resistant depression
On Jan. 21, 2025, Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.
MDD is one of the most common psychiatric disorders, with an estimated 21 million adults in the U.S. living with the disease. About one-third of adults will not respond to oral antidepressants alone, which has a significant negative impact on the quality of life of those affected. MDD has a high economic burden, with nearly half of it attributable to treatment-resistant depression (TRD).
SPRAVATO® is unique and works by targeting glutamate, which is the most abundant excitatory neurotransmitter in the brain. The mechanism by which esketamine exerts its antidepressant effect is unknown.
Backed by more than a decade of research and almost six years of real-world evidence, SPRAVATO® has proven to be a transformational treatment option for many patients with TRD by reducing depression symptoms in as little as 24 hours and reducing the time to relapse for patients who stay on treatment. To date, SPRAVATO® has been administered to more than 140,000 patients worldwide.
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Source: Johnson & Johnson
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