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 based on data from the SEP 361-201 study, a phase 2, placebo-controlled trial evaluating the efficacy and safety of SEP-363856 in acutely psychotic adults with schizophrenia.

Results showed that the treatment was associated with a statistically significant and clinically meaningful improvement in the Positive and Negative Syndrome Scale (PANSS) total score compared with placebo at Week 4 (primary endpoint; P=.001). Moreover, an improvement in the Clinical Global Impression scale-severity (CGI-S) score (P<.001) and PANSS subscale scores (P<.02) was also observed in patients treated with SEP-363856.

“Investigational studies to further evaluate the clinical benefit of SEP-363856 are in progress, and we look forward to working closely with the FDA on this important potential new therapy,” said Antony Loebel, MD, President and Chief Executive Officer at Sunovion.

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In addition to the schizophrenia indication, Sunovion is investigating SEP-363856 for the treatment of psychosis associated with Parkinson disease.

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This article originally appeared on MPR