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Neurobehavioral Disorders

Spravato Approved for MDD With Acute Suicidal Ideation or Behavior

The approval was based on the ASPIRE I and II trials that compared the efficacy and safety of esketamine, an N-methyl-D-aspartate receptor antagonist, to placebo in 449 adults with moderate to severe MDD who had active suicidal ideation and intent.
General Neurology

FDA to Review Tasimelteon for Smith-Magenis Syndrome

The applications are supported by positive results from a double-masked, 4-week, pivotal phase 2/3 clinical trial that compared the effects of tasimelteon to placebo in 25 patients with SMS.
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