Otsuka Pharmaceutical and Lundbeck have reported positive results from three Phase III studies evaluating the safety and efficacy of brexpiprazole for the treatment of schizophrenia patients experiencing severe psychotic symptoms.
Results are based on a pooled analysis of data obtained during the Vector, Beacon and Lighthouse studies.
The analysis included 681 patients, while the studies enroled patients with severe psychotic symptoms, measured on the basis of the total scores of the Positive and Negative Syndrome Scale (PANSS).
Among the patients, 427 were treated with 2mg-4mg of brexpiprazole and 254 received placebo. Patients showed an average baseline PANSS total score of 106.
Results also showed that patients receiving brexpiprazole experienced a mean improvement in PANSS total score of 24.03 against 17.27 for patients receiving placebo.
Response rates, defined as change from baseline greater than or equal to 30% in PANSS total score, were found to be higher for patients treated with brexpiprazole versus placebo.
These results were consistent with the patients with less severe symptoms.
Insomnia, headache and akathisia were the most common treatment-emergent adverse events reported in the trials.
Otsuka Pharmaceutical senior medical science liaison Nicole Meade said: “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.
“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.”
Brexpiprazole is a molecule jointly developed by Otsuka and Lundbeck.
In 2015, brexpiprazole was approved in the US for use as an adjunctive therapy to antidepressants in adults with major depressive disorder, and as a treatment for schizophrenia.