With educational financial support provided by Takeda and Sunovion Pharmaceuticals Europe, new data has been presented which shows both short and long-term efficacy for lurasidone, an atypical antipsychotic treatment for schizophrenia. These data also showed lurasidone to have early separation from placebo, a rapid onset of action, a favorable side effect profile and to be a well-tolerated, efficacious option for patients with schizophrenia switching medication. Lurasidone has been approved in U.S., Canada and Switzerland and currently is under regulatory review in Europe.
The data included a post-hoc analysis of double-blind controlled studies showing how insight (awareness of illness), when measured by PANSS score, was significantly improved for clinically unstable patients given once-daily lurasidone 80mg, lurasidone 160mg and active control quetiapine XR 600mg, compared to placebo, after six weeks. At week 32, insight was significantly greater for those treated with lurasidone compared with quetiapine XR. Increased insight was shown to predict improvements in specific cognitive measures.
Two post-hoc pooled analyses of a number of short-term trials demonstrated that lurasidone is an efficacious treatment with a favourable safety profile. One analysis demonstrated that lurasidone has early separation from placebo by week one and that the 160mg dosage may provide significant additional efficacy benefit. Side-effects were minimal regarding weight-gain, metabolic parameters and prolactin. The second analysis looked at patients with early-stage schizophrenia, as evidence suggests that they may be particularly sensitive to antipsychotics in general. In both analyses, those treated with lurasidone experienced significantly greater improvement at week six compared with placebo on PANSS total and subscale scores (positive and negative) and CGI-Severity score.
"As a dedicated psychiatrist, I am interested in new, effective agents for the treatment of severely ill patients with mental disorders. This is particularly true for patients who are not suitable for or who have not responded to currently approved therapeutics. We need effective, well-tolerated and metabolically neutral alternatives, which can also be used in young patients. Lurasidone has an interesting profile of action," said Dr. Philipp Eich, Stv Chefarzt, Kantonale Psychiatrische Klinik Liestal, Switzerland.
A further presentation of the results of two randomized controlled long-term (12-month) trials provided a head-to-head comparison of the safety and effectiveness of lurasidone and quetiapine XR (D1050234), and lurasidone and risperidone (D1050237). Lurasidone's side-effect profile was favorable compared to quetiapine XR. The safety profile showed, in part, clinically significant weight gain (defined as greater than or equal to7% weight gain from baseline) in 7% and 14% of patients treated with lurasidone v. risperidone, and in 11.5% and 15.2% of patients treated with lurasidone v. quetiapine, respectively.
Median changes in prolactin from baseline at month 12 were 0.0/+0.95ng/ml (for lurasidone, male/female) and +7.5/+24.6ng/ml (for risperidone, male/female). Overall, results of these two double-blind 12 month trials suggest that lurasidone was effective and well-tolerated over 12 months of treatment.
Minimal changes in weight and lipid parameters were also shown after six months in data evaluating the safety, tolerability and effectiveness of switching other antipsychotic medication to lurasidone. Switching antipsychotic medication is common in schizophrenia treatment either due to residual or emergent symptoms, adverse events or tolerability issues. Data from a randomized open-label switch extension study showed that lurasidone was well-tolerated and that switched patients generally maintained or improved their control of symptoms.
"The data show lurasidone provides efficacy in multiple aspects of the complex illness of schizophrenia. Lurasidone has a low incidence of side effects observed, whilst providing needed efficacy for patients with schizophrenia," said Tony Hale, medical director, Sunovion Pharmaceuticals Europe.
Takeda has submitted a marketing authorization application (MAA) for lurasidone in October 2012 to the European Medicines Agency (EMA).