Category Archive: FDA Approvals

Mar 22

Does the FDA Esketamine Approval Open the Door for Enrichment Trial Designs in Psychiatry?

By Greg Hileman, Ph.D, Senior Director of Regulatory Affairs and Principle Regulatory Scientist at Cato Research   On March 5, the FDA approved Spravato (esketamine) nasal spray, for use in conjunction with an oral antidepressant for treatment-resistant depression. Esketamine is the s-enantiomer of ketamine, approved in the 1970’s as an anesthetic, but used off-label since …

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