Breakthrough designation to schizophrenia drugJuly 5, 2019
SEP-363856, a novel psychotropic agent for the treatment of patients with schizophrenia, has received breakthrough designation from the US FDA.
SEP-363856 has a novel, non-D2 mechanism of action, distinct from currently marketed antipsychotics.
The drug candidate is being studied in a global development programme for schizophrenia as well as for Parkinson’s disease psychosis, with additional indications under consideration.
Clinical trial results to date demonstrate a predictable pharmacokinetic profile suitable for once daily use.
Historically, the treatment of schizophrenia has focused on blocking dopamine receptors. The results of the
phase 2 trial were found consistent in showing improvement in positive and negative symptoms, without the traditional side effects associated with dopamine blockers. The study met its primary endpoint, demonstrating that hospitalized patients with acute exacerbation 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. Patients treated with SEP-363856 also showed improvement in the overall severity of illness as assessed by the Clinical Global Impression Scale-Severity. In addition, the improvement was found in all major PANSS (positive, negative and general psychopathology) subscales.