▎WuXiangEdited by Kant Content Team

Johnson & Johnson announced today that it has submitted a supplemental new drug application (sNDA) to the U.S. FDA, seeking approval for its Spravato (esketamine) CIII nasal spray as a potential first monotherapy for the treatment of adult patients with refractory depression (TRD).Depressive symptoms in patients receiving Spravato monotherapy improved rapidly within about 24 hours and lasted for at least 4 weeks.

Currently, about 1 in 8 people worldwide suffer from mental illness. Among them, depression is one of the most common mental illnesses, with about 280 million patients worldwide. At the same time, nearly 2/3 of depression patients cannot get adequate relief from existing treatments. When patients with severe depression do not respond to 2 or more treatments, they may progress to refractory depression, and these patients have a huge demand for new treatments.

The submission is based on the positive results of the Phase 4 TRD4005 study, which evaluated the efficacy, safety and tolerability of Spravato as a single agent. This randomized, double-blind, multicenter, placebo-controlled study showed thatIn patients receiving SpravatofirstWithin 24 hours after treatment, the total score of the Montgomery-Asberg Depression Rating Scale (MADRS) improved rapidly, and this change lasted for at least 4 weeks.

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SpravatoThe safety of monotherapy was consistent with previous safety reports when used in combination with oral antidepressants, and no new safety issues were identified.

Last year, Johnson & JohnsonSpravatoPositive results in the Escape-TRD Phase 3b clinical trial for the treatment of TRD patients.Analysis shows thatPatients treated with Spravato were 1.54 times more likely to achieve remission after 8 weeks than those in the active control group. The detailed results of the trial were published in the New England Journal of Medicine.The results of this trial provide physicians with important information on the short-term and long-term efficacy of Spravato in treating refractory depression.

Spravato nasal spray is a non-selective, non-competitive NMDA receptor antagonist that may help repair neural connections in brain cells in people with depression.The therapy has been approved by the US FDA for use in combination with oral antidepressants to treat TRD and depression with acute suicidal thoughts or behaviors（MDSI）Adult patients. In April 2023, the drugChina approvedIn combination with oral antidepressants to relieve depressive symptoms in adults with major depressive disorder and acute suicidal ideation or behavior.

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