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Novel Treatment for Schizophrenia Gets FDA’s Breakthrough Therapy Designation

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to SEP-363856 (Sunovion), an investigational treatment for schizophrenia. SEP-363856 is believed to work by activating trace amine-associated receptor 1 (TAAR1) in addition to 5-HT1A receptors; unlike other antipsychotics, this novel agent does not bind to D2 or 5-HT2A receptors. The Breakthrough Therapy designation was…
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