Janssen's Nasal Spray Antidepressant Spravato® (Esketamine Hydrochloride) Approved in China for Rapid Relief of Depressive Symptoms in Adults with Active Suicidal Ideation or Behavior

On April 20, Xian Janssen announced that its product, Spravato® (Esketamine Hydrochloride Nasal Spray), received marketing authorization approval from the National Medical Products Administration for use in combination with oral antidepressants to alleviate depressive symptoms in adult patients with major depressive disorder who have acute suicidal ideation or behavior.

Spravato® (Esketamine Hydrochloride Nasal Spray), as the first antidepressant drug with a novel mechanism of action and route of administration approved in China, can rapidly alleviate depressive symptoms in adult patients with major depressive disorder accompanied by acute suicidal ideation or behavior. Existing antidepressants predominantly target the monoamine pathway and generally require 4-6 weeks to achieve full therapeutic efficacy. Unlike these, Spravato® exerts its antidepressant effect by antagonizing the N-methyl-D-aspartate (NMDA) receptor and is administered via nasal spray, enabling rapid onset of action.

The two pivotal global Phase III clinical studies supporting the marketing authorization approval of this product demonstrated that, in adult patients with depression accompanied by acute suicidal ideation or behavior, compared with placebo nasal spray combined with standard treatment (oral antidepressants), Spravato® combined with standard treatment showed clinically meaningful and statistically significant improvement in depressive symptoms as early as 24 hours after the first dose. The benefits of depressive symptom improvement were observed as early as 4 hours after the first dose. These two studies also indicated that this product provided continuous improvement of depressive symptoms from 4 hours to 25 days after the first dose, with a higher proportion of patients achieving clinical remission (MADRS total score ≤12) compared to placebo nasal spray combined with standard treatment.

In China, the lifetime prevalence of adult depression is 3.4%, and suicidal ideation or behavior is one of the main symptoms of depression. More than 50% of Chinese patients with depression have experienced suicidal ideation, and 23.7% of patients have attempted suicide. The slow onset of existing treatment methods constantly exposes patients and their families to the potential risk of suicide caused by depression.

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