Sunovion and PsychoGenics Announce Positive Results from Pivotal Phase 2 Study of Novel Investigational Agent SEP-363856 for the Treatment of Schizophrenia

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MARLBOROUGH, Mass. & PARAMUS, N.J.–(Business Wire)–Sunovion Pharmaceuticals Inc. (Sunovion) and PsychoGenics Inc. (PsychoGenics), today announced that positive results from SEP 361-201, a pivotal Phase 2 study that evaluated the efficacy and safety of SEP-363856, a novel psychotropic agent for the treatment of patients with schizophrenia, were presented at the 57th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in Hollywood, Fla.

The study met its primary endpoint, demonstrating that hospitalized patients with acute exacerbation (worsening) of schizophrenia treated with SEP-363856 showed statistically significant and clinically meaningful improvement in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo after four weeks of treatment (-17.2 vs. -9.7, respectively; p=0.001). Patients treated with SEP-363856 also showed improvement in the overall severity of illness as assessed by the Clinical Global Impression Scale - Severity (CGI-S) (p<0.001). In addition, improvement was found in all major PANSS (positive, negative and general psychopathology) subscales (p<0.02).

http://www.digitaljournal.com/pr/4068950

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Interesting. They aren’t sure exactly how it works.

SEP-363856 does not bind to D2 or other dopaminergic receptors or to serotonergic receptors (except for 5-HT1A), which are thought to mediate the effects of currently available antipsychotic medicines. Although the exact mechanism of action is unknown, SEP-363856 is believed to activate TAAR1 (trace amine-associated receptor 1) in addition to 5-HT1A (serotonin 1A) receptors.

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Side effects:

Adverse events occurring in at least two percent of patients and in the SEP-363856 group (with the higher incidence in the SEP-363856 group), included somnolence (6.7 percent and 4.8 percent), agitation (5.0 percent and 4.8 percent), nausea (5.0 percent and 3.2 percent), diarrhea (2.5 percent and 0.8 percent) and dyspepsia (2.5 percent and 0.0 percent). Additionally, change in weight, lipids, glucose and prolactin associated with SEP-363856 treatment was similar to placebo during the study. The proportion of patients who experienced extrapyramidal symptoms treated with SEP-363856 and placebo was 3.3 and 3.2 percent, respectively.

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Could be the first new novel drug on the market, heres hoping.

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Would be nice to see something that didn’t block dopamine out there. Makes me wonder how this disease works and how current medication works.

Seems there is a lot people don’t understand still.