Sunovion Pharmaceuticals has announced positive findings from the SEP361-202 open-label extension study of SEP-363856 in patients with schizophrenia.
Discovered in alliance with PsychoGenics, SEP-363856 is an agonist of trace amine-associated receptor 1 (TAAR1) and serotonin 1A (5-HT1A) receptors. The drug is being developed to treat schizophrenia and psychosis associated with Parkinson’s disease.
In May this year, the Food and Drug Administration (FDA) awarded breakthrough therapy designation for SEP-363856 to treat schizophrenia.
The open-label extension study assessed the long-term safety and effectiveness of the drug over 26 weeks in 157 patients who completed the four-week, double-blind treatment phase of SEP361-201 study.
About 66% of participants completed the open-label study and 11.5% discontinued because of an adverse event.
Results showed that SEP-363856 was generally safe and well-tolerated, without any clinically meaningful changes in metabolic parameters or prolactin levels.
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In addition, the drug led to clinically meaningful improvements on the efficacy measures of Positive and Negative Syndrome Scale (PANSS) total score, the Clinical Global Impression Scale – Severity (CGI-S) score and the Brief Negative Symptom Scale (BNSS) total score.
Disease exacerbation, headache, insomnia and anxiety occurred in at least 5% of patients.
Sunovion Pharmaceuticals Psychiatry global clinical research head Justine Kent said: “The results of our six-month, open-label extension study in patients living with schizophrenia demonstrate that SEP-363856 has an excellent long-term safety profile, with continued, clinically meaningful improvement seen in the PANSS total score.
“We look forward to swiftly progressing our global Phase III clinical studies of SEP-363856 in both adult and adolescent patients with schizophrenia.”
Schizophrenia is a chronic and severely disabling brain disorder that causes hallucinations, delusions, disorganised thinking, social withdrawal and cognitive impairment, among other symptoms.