¡New FDA approval for treatment of major depressive disorder – From darkness to light!
Some patients have improvements within 24 hours
after administration
January 23 2025
On January 22, 2025, the U.S. Food and Drug Administration (FDA) granted approval to Spravato (esketamine) nasal spray.
This medication is a treatment option for adults with rmajor depressive disorder (MDD) who have not responded adequately to at least two prior oral antidepressants. This approval makes Spravato the first and only approved monotherapy for people with treatment-resistant depression. The approval was based on the results of a rigorous, randomized, double-blind, multicenter, placebo-controlled clinical trial.
En el ensayo, los pacientes que recibieron Spravato mostraron mejoras significativas en sus síntomas depresivos. Después de 28 días, el 22.5% de los pacientes que tomaron Spravato lograron la remisión, definida como una puntuación en la Escala de Calificación de Depresión de Montgomery-Åsberg (MADRS) de 12 o menos, en comparación con solo el 7.6% de los pacientes en el grupo placebo.
In the trial, patients receiving Spravato showed significant improvements in their depressive symptoms. After 28 days, 22.5% of patients taking Spravato achieved remission, defined as a Montgomery-Åsberg Depression Rating Scale (MADRS) score of 12 or less, compared with only 7.6% of patients in the placebo group.
In addition, improvements were seen in all 10 items of the MADRS. Spravato works by targeting the neurotransmitter glutamate, although the exact mechanism by which it relieves depression is not yet fully understood. The nasal spray is self-administered by patients under the supervision of a healthcare provider in a clinical setting. This is due to potential side effects such as sedation, dissociation, respiratory depression, and the risk of abuse or misuse.
To ensure that the drug is used safely, Spravato is only available through the restricted Spravato Risk Evaluation and Mitigation Strategy (REMS) program. This program aims to minimize the risks associated with the drug and ensures that patients are appropriately monitored during its use.
Bill Martin, Ph.D., global therapeutic area head for neuroscience at Johnson & Johnson Innovative Medicine, highlighted the importance of Spravato, noting that treatment-resistant depression is a complex condition, and many patients previously had few options for meaningful symptom improvement. With Spravato, patients can experience improvements as early as 24 hours after administration, making it a valuable new tool for treating this challenging form of depression.