ByMedView

On January 27, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Janssen had submitted a market application for esketamine hydrochloride nasal spray, a new drug classified under Category 5.1, which has been accepted. Public information indicates that this is the esketamine nasal spray Spravato developed by Janssen, which was approved for marketing in the United States in 2019. It is the first antidepressant with a novel mechanism of action approved by the FDA in 30 years, representing a significant breakthrough in the field of depression treatment.

Screenshot source: CDE official website

According to the World Health Organization (WHO), approximately 5% of adults worldwide suffer from depression, with over 300 million people affected by the condition. Some patients with depression continue to experience symptoms despite receiving multiple antidepressant treatments, indicating an unmet clinical need.

Esketamine Nasal Spray Developed by Janssen Pharmaceuticals is the S-enantiomer of ketamine. Ketamine is commonly used as an anesthetic in medical practice. However, researchers have also found that ketamine can alleviate depressive symptoms within a few hours of administration, whereas typical antidepressant medications take weeks to become effective.

From the mechanism of action, esketamine nasal spray is a non-selective, non-competitive NMDA receptor antagonist. It can specifically modulate NMDA receptors, which may potentially help repair neuronal connections in brain cells of patients with depression. As most existing depression therapies work by acting on serotonin signaling networks, esketamine represents an innovative mechanism of action.

In March 2019, esketamine nasal spray was approved for marketing in the United States, to be used in combination with oral antidepressants for the treatment of adult patients with severe depression who are resistant to existing therapies. According to a press release issued by Janssen Pharmaceuticals at the time, this is the first drug to treat depression using a new mechanism of action in 30 years. This approval was based on the results of five pivotal clinical trials, which showed that the combination of esketamine nasal spray and newly administered oral antidepressants could rapidly alleviate depressive symptoms and delay the recurrence of depression.

In August 2020, the supplemental New Drug Application (sNDA) for esketamine nasal spray was again approved by the FDA for use in combination with oral antidepressants to treat depressive symptoms in adults with major depressive disorder (MDD) accompanied by acute suicidal ideation or behavior. This approval was based on the results of two identical Phase 3 clinical trials, which showed that the candidate drug, combined with comprehensive standard care, significantly and rapidly reduced depressive symptoms within 24 hours. Janssen Pharmaceuticals noted in a press release that esketamine is the first FDA-approved drug to demonstrate relief of depressive symptoms within 24 hours, offering a new option for significant symptom relief.

Depression is one of the leading causes of disability worldwide and a common condition associated with suicide. The illness can significantly negatively impact how people think, feel, and behave. Symptoms and severity vary from person to person and may include persistent feelings of sadness, hopelessness, or anxiety, changes in sleep or appetite, difficulty concentrating or performing daily activities, loss of interest, and thoughts of self-harm. If severe depression progresses to active suicidal ideation, it can be devastating.

References:

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China - Information on Accepted Drug Products. Retrieved Jan 27, 2022, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[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] Janssen Announces U.S. FDA Approval of SPRAVATO® (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior. Retrieved August 3, 2020, fromhttps://www.prnewswire.com/news-releases/janssen-announces-us-fda-approval-of-spravato-esketamine-ciii-nasal-spray-to-treat-depressive-symptoms-in-adults-with-major-depressive-disorder-with-acute-suicidal-ideation-or-behavior-301104437.html

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