▎WuXiEdited by Kant Content Team

Johnson & Johnson today announced 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-line monotherapy for treating adults with treatment-resistant depression (TRD). Trial results show,Depressive symptoms in patients receiving Spravato monotherapy rapidly improved in approximately 24 hours and persisted for at least 4 weeks.

Currently, about 1 in every 8 people worldwide suffers from a mental illness. Among these, depression is one of the most common mental illnesses, with approximately 280 million patients globally. Meanwhile, nearly two-thirds of individuals with depression do not achieve adequate relief from existing therapies. When patients with major depressive disorder fail to respond to two or more treatment methods, their condition may progress to treatment-resistant depression, creating a significant demand for new therapeutic approaches.

This submission is primarily based on the positive results of the TRD4005 Phase 4 clinical study, which evaluated the efficacy, safety, and tolerability of Spravato as a monotherapy. This randomized, double-blind, multicenter, placebo-controlled study demonstrated thatDuring the patient's treatment with SpravatoFor the first timeWithin 24 hours after treatment, their Montgomery-Åsberg Depression Rating Scale (MADRS) total score improved rapidly, and this change lasted for at least 4 weeks.

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SpravatoThe safety of monotherapy is consistent with the safety observed when used in combination with oral antidepressants, and no new safety issues were identified.

Johnson & Johnson last yearPublicationSpravatoPositive Results in the Treatment of TRD Patients in the Escape-TRD Phase 3b Clinical Trial.The analysis shows,Patients receiving Spravato treatment were 1.54 times more likely to achieve remission after 8 weeks compared to the active control group. Detailed trial results were published in The New England Journal of Medicine.This trial result provides doctors with important information on the short-term and long-term efficacy of using Spravato to treat treatment-resistant depression.

Spravato Nasal Spray is a non-selective, non-competitive NMDA receptor antagonist that may help repair neural connections in the brain cells of patients with depression.This therapy has been approved by the U.S. FDA for use in combination with oral antidepressant medications to treat TRD and depression accompanied by acute suicidal ideation or behavior.（MDSI）Adult patients. In April 2023, the drug wasApproved in ChinaRelieve depressive symptoms in adult patients with major depressive disorder accompanied by acute suicidal ideation or behavior, in combination with oral antidepressants.

References:

[1] Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (https://www.investor.jnj.com/news/news-details/2024/Johnson--Johnson-seeks-U.S.-FDA-approval-of-SPRAVATO-esketamine-as-the-first-and-only-monotherapy-for-adults-with-treatment-resistant-depression/default.aspx) as the first and only monotherapy for adults with treatment-resistant depression. Retrieved July 22, 2024 from https://www.investor.jnj.com/news/news-details/2024/Johnson--Johnson-seeks-U.S.-FDA-approval-of-SPRAVATO-esketamine-as-the-first-and-only-monotherapy-for-adults-with-treatment-resistant-depression/default.aspx

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