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Novel Agent Promising for the Treatment of Schizophrenia

Reduction in PANSS total score greater for non-D2-receptor-binding drug SEP-363856 versus placebo

THURSDAY, April 16, 2020 (HealthDay News) — For patients with an acute exacerbation of schizophrenia, SEP-363856, a non-D2-receptor-binding drug that has agonist activity at trace amine-associated receptor 1 (TAAR1) and 5-hydroxytryptamine type 1A receptors, reduces Positive and Negative Symptom Scale (PANSS) total score more than placebo, according to a study published in the April 16 issue of the New England Journal of Medicine.

Kenneth S. Koblan, Ph.D., from Sunovion Pharmaceuticals in Marlborough, Massachusetts, and colleagues conducted a randomized trial to assess the efficacy and safety of SEP-363856 in adults with an acute exacerbation of schizophrenia. Patients were randomly assigned to either once-daily SEP-363856 or placebo for four weeks (120 and 125 patients, respectively).

The researchers found that the mean change in the PANSS total score was −17.2 and −9.7 points, respectively, in the SEP-363856 and placebo groups (least-squares mean difference, −7.5 points). At week 4, the reductions in the Clinical Global Impressions Severity and Brief Negative Symptom Scale scores were generally in the same direction; the results were not adjusted for multiple comparisons. Somnolence and gastrointestinal symptoms were included as adverse events with SEP-363856; there was one sudden cardiac death in the SEP-363856 group.

“The report by Koblan et al not only introduces a promising therapeutic compound but also provides additional evidence, on the basis of an agnostic drug-discovery process, that TAAR1 is a promising target,” write the authors of an accompanying editorial.

The study was funded by Sunovion Pharmaceuticals, the developer of SEP-363856.

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