Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced study results on the safety and efficacy of brexpiprazole in the treatment of patients with schizophrenia experiencing severe psychotic symptoms during an acute episode. The data will be presented at the upcoming Psych Congress, held in Orlando from October 25-28, 2018.
The post hoc, pooled analysis focused on three short-term studies, Vector [NCT01396421], Beacon [NCT01393613], and Lighthouse [NCT01810380], evaluating brexpiprazole in subgroups of patients with severe psychotic symptoms. Patients with severe psychotic symptoms were defined based on the total scores of the Positive and Negative Syndrome Scale (PANSS), a scale used to rate the symptoms of schizophrenia. Patients with severe psychotic symptoms were specified by having PANSS total scores of greater than 95, which was the median score of the full patient population at baseline.
The 681 patients included in the analysis exhibited an average baseline PANSS total score of 106 with 427 patients given a dose of 2-4 mg of brexpiprazole and 254 given placebo. The study demonstrated that patients receiving brexpiprazole showed a mean improvement in PANSS Total score of 24.03 vs. 17.27 for patients receiving placebo (placebo-adjusted difference of 6.76, p<0.0001). Response rates (defined as change from baseline greater than or equal to 30% in PANSS Total Score or CGI-I score of 1 or 2 at Week 6 of the study) were greater for those patients treated with brexpiprazole versus placebo (46.9% and 27.3%, respectively, p<0.0001). Similar results were observed for patients with less severe symptoms (i.e. patients with baseline PANSS score less than 95). The most common treatment emergent adverse events (occurring in greater than or equal to 5% of patients in any group) included insomnia, headache and akathisia and were similar between patients with more or less severe psychotic symptoms.
"Schizophrenia is a chronic, disabling and progressive disease, impacting approximately three million Americans, that is often challenging to treat, and the severity of schizophrenia symptoms can be a significant predictor of poor treatment outcomes," said Nicole Meade, PhD, Senior Medical Science Liaison, Otsuka. "These results underscore the potential of brexpiprazole as an effective treatment option with a safety profile that can provide physicians the confidence to prescribe it to patients with schizophrenia with a broad range of symptoms, including those with more severe psychotic symptoms."