US-based Johnson & Johnson (J&J; NYSE: JNJ) has announced that its Spravato (esketamine) CIII nasal spray has received clearance from the US Food and Drug Administration (FDA) as the first and only monotherapy for adults with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants. This approval expands the therapeutic options for patients struggling with treatment-resistant depression.
Spravato: Mechanism and Previous Approvals
Spravato is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, believed to work by acting on a pathway in the brain that affects glutamate. First approved in 2019 for treatment-resistant depression (TRD), the drug was later approved in 2020 for use in combination with oral antidepressants to treat depressive symptoms in adults with TRD and severe depression accompanied by acute suicidal ideation or behavior.
Global Reach and Impact
Spravato is now registered in 77 countries and regions worldwide, having benefited over 140,000 patients. The latest FDA clearance for monotherapy use further solidifies Spravato’s position as a significant treatment option for patients with major depressive disorder, particularly those who have not responded adequately to traditional antidepressants.-Fineline Info & Tech
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