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Allergan's Rapastinel Receives FDA Breakthrough Therapy Designation for Adjunctive Treatment of Major Depressive Disorder

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The Breakthrough Therapy designation was based on preclinical and preliminary clinical evidence for rapastinel, which supports a rapid (within 1 day) and sustained antidepressant effect over the course of the Phase II studies. Rapastinel has been found to be well tolerated in studies to date, with no psychotomimetic or hallucinogenic side effects observed.
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Occurred on:
Jan 29, 2016
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Related Keywords Rapastinel, Breakthrough Therapy Designation, Fda, Major Depressive Disorder