Janssen’s Spravato (esketamine) has been granted approval by the National Medical Products Administration (NMPA) in China for the alleviation of depressive symptoms in adult patients with acute suicidal ideation or behavior when used in combination with an oral antidepressant.
Spravato: A Novel Antidepressant with Rapid-Onset Action
Spravato marks a significant advancement as the first antidepressant approved in China featuring a new mechanism of action and delivery method. It is designed to quickly alleviate depressive symptoms in adults with acute suicidal ideation or behavior. While traditional antidepressants primarily act on the monoamine pathway and can take 4 to 6 weeks to achieve full efficacy, Spravato differentiates itself by antagonizing the N-methyl-D-aspartate (NMDA) receptor, enabling rapid relief through a nasal spray administration.
Clinical Efficacy and Global Approvals
Spravato nasal spray was first approved for marketing in the US in March 2019, with clinical data demonstrating effects as early as four hours post-administration. It is recognized as the first and only drug proven to alleviate depressive symptoms within 24 hours. This rapid onset of action addresses a critical unmet need in the treatment of severe depression.
Ketamine’s Legacy and Generic Developments
Ketamine, the parent compound of esketamine, was originally developed by Parke Davis and later acquired by Pfizer for the development of Ketanest S. In China, Hengrui Medicine’s first-mover generic version of the drug received approval in November 2019, further expanding access to this important class of medications.-Fineline Info & Tech
