FDA Approves Nasal Spray To Tackle Depression
The U.S. Food and Drug Administration (FDA) has approved Spravato (esketamine) nasal spray for adults with major depressive disorder who have not responded adequately to at least two oral antidepressants, according to a statement from Johnson & Johnson. This approval marks Spravato as the first and only approved monotherapy for individuals with treatment-resistant depression.
Spravato’s approval follows the completion of a rigorous clinical trial, which included a randomized, double-blind, placebo-controlled study. Results showed that, after four weeks of treatment, 22.5% of patients using Spravato experienced remission, defined by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 12 or lower. This was a significant improvement compared to just 7.6% of patients receiving the placebo.
The medication is administered as a nasal spray under the supervision of a healthcare provider in a clinical setting. Spravato targets the glutamate neurotransmitter, though the exact mechanism by which it works to alleviate depression is still not fully understood. To minimize risks associated with its use, such as sedation, dissociation, and potential for misuse, Spravato is only available through a restricted program called the Spravato Risk Evaluation and Mitigation Strategy.
Dr. Bill Martin, Global Therapeutic Area Head for Neuroscience at Johnson & Johnson, emphasized the significance of this approval, noting that for patients who do not respond to or tolerate traditional antidepressants, treatment-resistant depression can be challenging. He highlighted that Spravato offers a potential solution, providing symptom relief as early as 24 hours after administration, with continued improvement over the following 28 days, all without the need for daily oral medications.
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