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Novel psychotropic agent shows promise for schizophrenia
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Sunovion Pharmaceuticals and PsychoGenics have announced positive results from a pivotal phase 2 study evaluating the efficacy and safety of SEP-363856, a novel psychotropic agent for schizophrenia, according to a press release.
SEP-363856, which does not bind to dopamine 2, other dopaminergic receptors or to serotonergic receptors, is thought to activate trace amine-associated receptor 1 and 5-HT1A (serotonin 1A) receptors, the release said.
In the study, known as Study 361-201, hospitalized patients with acute exacerbation of schizophrenia who received treatment with SEP-363856 demonstrated statistically significant and clinically meaningful improvement in the Positive and Negative Syndrome Scale (PANSS) total score compared with placebo after 4 weeks (–17.2 vs. –9.7; P = .001).
In addition, patients receiving SEP-363856 also showed improvement in the overall severity of illness measured via the Clinical Global Impression Scale - Severity (P < .001) and in all major PANSS subscales (P < .02).
SEP-363856 was generally well-tolerated, according to the release. Discontinuation rates, proportion of patients experiencing extrapyramidal symptoms or akathisia, and change in metabolic parameters (ie, weight, lipids, glucose and prolactin) were similar among patients receiving SEP-363856 and those receiving placebo.
“For more than 60 years, the treatment of schizophrenia has focused on blocking dopamine receptors. Finding a schizophrenia medication that works outside of a direct action on the dopamine system would be highly desirable,” Shitij Kapur, MBBS, PhD, FRCPC, dean of the faculty of medicine, University of Melbourne, Australia, said in the release. “The results need to be replicated in further studies and broader populations, but, if these results hold, it could be a remarkable advance for patients and health care providers, as well as a great new avenue for exploration of new scientific mechanisms for psychotic disorders.”
Disclosure: Healio Psychiatry was unable to confirm any relevant financial disclosures at the time of publication.