PM385. Long-term safety of brexpiprazole (OPC-34712) in schizophrenia: results from two 52-week open-label studies

s | 41 Conclusion: Clinically relevant improvements in psychopathology were observed in patients with acute schizophrenia treated with brexpiprazole or aripiprazole. Brexpiprazole was well tolerated with a lower incidence of EPS-related adverse events than aripiprazole. PM385 Long-term safety of brexpiprazole (OPC-34712) in schizophrenia: results from two 52-week open-label studies Christoph U. Correll MD1, Aleksandar Skuban MD2, John Ouyang PhD2, Emmanuelle Weiller PsyD3, Catherine Weiss PhD2 1The Zucker Hillside Hospital, Glen Oaks, NY, USA 2Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA 3H. Lundbeck A/S, Valby, Denmark Abstract Background: The long-term safety and tolerability of brexpiprazole were evaluated in patients with schizophrenia, based on pooled data from two large open-label extension studies. Methods: These two studies were open-label, 52-weeks, flexible-dose (study 1 [NCT01649557]: 1 to 6mg/day and study 2 [NCT01397786]: 1 to 4mg/day) studies with brexpiprazole. Study 1 enrolled patients who had completed a phase II study (NCT00905307) while study 2 enrolled de novo patients as well as patients who had completed one of the two pivotal phase III studies in acute schizophrenia (NCT01396421[1] or NCT01393613[2]). As study 2 is still ongoing, the data presented are based on a data-cut from 15-May-2015. Results: A total of 1059 patients entered the studies [28 from study 1 and 1031 from study 2 of which 224 were de novo patients]. Of these, 34.0% (360/1059) completed 52 weeks of treatment. Adverse events reported by ≥5% of the patients in the extension studies were schizophrenia (10.7%), insomnia (8.0%), weight increased (7.7%), headache (6.0%), and agitation (5.2%); the adverse event profile was similar to what was observed in the short-term lead-in studies. The mean weight gain was 1.5kg at week 26 (N=485) and 2.2kg at week 52 (N=357) for the observed cases, and 0.5% (5/1059) of patients discontinued due to treatment-emergent adverse events associated with weight increase. The increases in body weight were not accompanied by meaningful changes in lipid profiles or glycemic parameters. Conclusion: Long-term treatment with brexpiprazole (1 to 6mg daily) was safe and well tolerated in patients with schizophrenia, as evaluated in two open-label extension studies.Background: The long-term safety and tolerability of brexpiprazole were evaluated in patients with schizophrenia, based on pooled data from two large open-label extension studies. Methods: These two studies were open-label, 52-weeks, flexible-dose (study 1 [NCT01649557]: 1 to 6mg/day and study 2 [NCT01397786]: 1 to 4mg/day) studies with brexpiprazole. Study 1 enrolled patients who had completed a phase II study (NCT00905307) while study 2 enrolled de novo patients as well as patients who had completed one of the two pivotal phase III studies in acute schizophrenia (NCT01396421[1] or NCT01393613[2]). As study 2 is still ongoing, the data presented are based on a data-cut from 15-May-2015. Results: A total of 1059 patients entered the studies [28 from study 1 and 1031 from study 2 of which 224 were de novo patients]. Of these, 34.0% (360/1059) completed 52 weeks of treatment. Adverse events reported by ≥5% of the patients in the extension studies were schizophrenia (10.7%), insomnia (8.0%), weight increased (7.7%), headache (6.0%), and agitation (5.2%); the adverse event profile was similar to what was observed in the short-term lead-in studies. The mean weight gain was 1.5kg at week 26 (N=485) and 2.2kg at week 52 (N=357) for the observed cases, and 0.5% (5/1059) of patients discontinued due to treatment-emergent adverse events associated with weight increase. The increases in body weight were not accompanied by meaningful changes in lipid profiles or glycemic parameters. Conclusion: Long-term treatment with brexpiprazole (1 to 6mg daily) was safe and well tolerated in patients with schizophrenia, as evaluated in two open-label extension studies.