Dainippon Sumitomo Pharma America (DSPA), a US subsidiary of Dainippon Sumitomo Pharma (DSP), has submitted a New Drug Application (NDA) to the FDA for Lurasidone, an investigational atypical antipsychotic agent for the treatment of schizophrenia. The application, submitted on December 30, 2009, includes data from more than 40 clinical studies involving more than 2,500 lurasidone-treated patients.
Reportedly, the efficacy of once-daily Lurasidone was demonstrated in four six-week, placebo-controlled studies, involving hospitalised patients with schizophrenia. These studies included the global PEARL 1 and PEARL 2 clinical trials (Program to Evaluate the Antipsychotic Response to Lurasidone).
The results of the study suggested that in the study Lurasidone was generally well-tolerated with limited weight gain or changes in metabolic parameters. Furthermore, Lurasidone was associated with mild changes in movement disorder parameters and prolactin levels.
Masayo Tada, president and CEO of DSP, said: “This NDA marks a significant milestone for our company as we accelerated the global clinical development of lurasidone and achieved an earlier than anticipated submission to the FDA. We believe Lurasidone will be a valuable new option for patients, their families and physicians for the treatment of schizophrenia.”
Antony Loebel, vice president of clinical development at DSPA, said: “Lurasidone may offer physicians a new, once-daily treatment option for schizophrenia, where many unmet needs remain. We believe lurasidone has the potential to treat the symptoms of schizophrenia, while limiting troublesome side effects, such as weight gain and related metabolic risks.”