Category Archive: Neurology

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 …

Continue reading »

Mar 05

TRAUMATIC BRAIN INJURY

By Mabel Ruscitti and Arnavaz Eduljee, Cato Research AWARENESS: Traumatic Brain Injury (TBI) occurs from a blow, jolt, bump or a penetrating object to the head.[1, 2] Traumatic brain injury can lead to brain cell death, inflammation, edema, hemorrhage, and severe disruption to normal brain cell function.  Concussion injury frequently results in persistent functional impairment …

Continue reading »