Janssen, a subsidiary of Johnson & Johnson, announced,China's National Medical Products Administration (NMPA) has approved the marketing of its esketamine hydrochloride nasal spray.For use in combination with oral antidepressants to alleviate depressive symptoms in adult patients with major depressive disorder accompanied by acute suicidal ideation or behavior.. Public information shows that esketamine hydrochloride nasal spray (esketamine) isAn N-Methyl-D-Aspartate (NMDA) Receptor Antagonist。

It is reported that as an NMDA receptor antagonist, esketamine hydrochloride nasal spray can specifically modulate NMDA receptors, which may potentially help repair neuronal connections in the brain cells of patients with depression. Unlike existing antidepressant drugs, which mostly function through the monoamine pathway, esketamine hydrochloride nasal spray...Exerts antidepressant effects by antagonizing NMDA receptors and adopts a novel intranasal administration method, enabling rapid onset of action.. This drug has received the Breakthrough Therapy Designation from the U.S. FDA twice for the treatment of refractory depression and severe depression patients with suicidal risk.

Previously, esketamine hydrochloride nasal spray has been approved in the United States, Canada, the European Union, and other countries and regions for use in combination with oral antidepressants to treat adult patients with treatment-resistant depression (TRD) and major depressive disorder with acute suicidal ideation or behavior (MDSI). This time, in China, the drug has been approved.Relief of depressive symptoms in adult patients with major depressive disorder accompanied by acute suicidal ideation or behavior, in combination with oral antidepressants。

In two global Phase 3 clinical trials (ASPIRE I and ASPIRE II), researchers evaluated the efficacy and safety of esketamine hydrochloride nasal spray in treating adult patients with depression (MADRS total score >28) who had active suicidal ideation and intent. The data from these two clinical trials demonstrated that, in adult patients with depression accompanied by acute suicidal ideation or behavior, compared to the placebo nasal spray combined with standard treatment group,Esketamine Hydrochloride Nasal Spray Combined with Standard Treatment Shows Significant Statistical Improvement in Depressive Symptoms Within 24 Hours After the First Dose, with Observable Reduction in Depressive Symptoms as Early as 4 Hours After the First AdministrationFrom 4 hours to 25 days after administration, the drug continuously improved depressive symptoms in patients. Compared with placebo nasal spray combined with standard treatment, the proportion of patients achieving clinical remission (MADRS total score ≤12) was significantly higher in the esketamine hydrochloride nasal spray group.

Depression is one of the most common mental illnesses in adults, with suicidal ideation or behavior being a primary symptom. These patients have significant unmet clinical needs. It is hoped that esketamine hydrochloride nasal spray will soon become available to patients, offering them a new treatment option.

References:

[1] Janssen announces the approval of the antidepressant drug Spravato® in China. Retrieved Apr 20, 2023, from https://mp.weixin.qq.com/s/5tUGQjDHyq5y6Ri2LyCodw

[2] FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor's office or clinic. Retrieved March 6, 2019, from https://www.prnewswire.com/news-releases/fda-approves-new-nasal-spray-medication-for-treatment-resistant-depression-available-only-at-a-certified-doctors-office-or-clinic-300807354.html
[3] Esketamine Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Major Depressive Disorder with Imminent Risk for Suicide. Retrieved Aug 16, 2016, from https://www.jnj.com/media-center/press-releases/esketamine-recieves-breakthrough-therapy-designation-from-us-food-and-drug-administration-for-major-depressive-disorder-with-imminent-risk-of-suicide

[4] SPRAVATO® (Esketamine Nasal Spray) Authorised in Europe for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Patients with Major Depressive Disorder. Retrieved Feb 8, 2021,  from https://www.jnj.com/:~:text=BEERSE,%20BELGIUM,%20February%208,%202021%20%E2%80%93%20The%20Janssen,to%20clinical%20judgement%20constitute%20a%20psychiatric%20emergency.%207

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