Dainippon Sumitomo Pharma Co, Ltd, (DSP) announced positive results from PEARL-2 - a phase-3 clinical trial of lurasidone for the treatment of patients with schizophrenia. In this trial, both lurasidone 40 and 120 mg/day were significantly more effective than placebo for the treatment of schizophrenia. Lurasidone was well-tolerated with an overall discontinuation rate that was similar to placebo.

"We are pleased with the results of this study as these data reinforce our belief that lurasidone will be an important treatment option for patients with schizophrenia," said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co, Ltd. "We plan to submit our NDA filing package for lurasidone to the US FDA in early 2010."

PEARL 2 (Programme to Evaluate the Antipsychotic Response to Lurasidone) is part of an extensive worldwide phase-3 clinical development program, involving more than 2,000 patients, intended to evaluate the safety and efficacy of lurasidone for the treatment of schizophrenia. The PEARL-2 study was a double-blind, fixed-dose, placebo-controlled clinical trial involving 478 inpatients with acute schizophrenia that were randomized to receive either lurasidone 40 or 120 mg/day, olanzapine 15 mg/day or placebo for six weeks. The active comparator, olanzapine, was used for purposes of establishing assay sensitivity.

Lurasidone 40 and 120 mg, taken once-daily, demonstrated significantly greater improvement versus placebo on the primary efficacy measure, the Positive and Negative Syndrome Scale (PANSS) total score, at study endpoint. PANSS score changes from baseline for lurasidone 40 and 120 mg/day versus placebo were -25.7 and -23.6 vs. -16.0, respectively, at study endpoint. A total of 53 per cent of patients on lurasidone 40 mg/day and 47 per cent of patients on lurasidone 120 mg/day demonstrated a 30 per cent or more improvement on the PANSS total score from baseline versus 38 per cent on placebo. In addition, both lurasidone dose groups were significantly more effective than placebo on the Clinical Global Impressions Severity scale (CGI-S), the key secondary efficacy endpoint. The CGI-S score changes from baseline for lurasidone 40 and 120 mg/day versus placebo were -1.5 and -1.4 vs. -1.1, respectively, at study endpoint.

"Patients with schizophrenia and their health care providers are in need of new treatment options that provide consistent efficacy with a lower impact on weight, lipids, and movement disorders," said Herbert Meltzer, a study investigator and professor of psychiatry and pharmacology at the Vanderbilt University School of Medicine. "Lurasidone appears to be a potentially significant new treatment option for schizophrenia."

"PEARL 2 data are consistent with previous lurasidone placebo-controlled studies and underscore the potential of lurasidone to effectively treat patients with schizophrenia," said Antony Loebel, vice president of clinical research, Dainippon Sumitomo Pharma America, Inc. Lurasidone was also well-tolerated with an overall discontinuation rate similar to placebo (40% vs. 39% placebo) and few adverse event-related discontinuations (9% for both the overall lurasidone group and placebo). Adverse events seen in the trial were generally mild. The most commonly reported adverse events for lurasidone 40 and 120 mg/day combined (greater than 5% and at least twice the rate of placebo) were akathisia (17.3% vs. 0.9% placebo), somnolence (12.2% vs. 4.3% placebo), sedation (11.4% vs. 3.4% placebo), parkinsonism (10.1% vs. 1.7% placebo), nausea (9.3% vs. 4.3% placebo), and dystonia (5.5% vs. 0.9% placebo).

The company has submitted the results of the trial for presentation at a scientific meeting at the end of this year.

Lurasidone is an atypical antipsychotic discovered and developed by DSP with a unique chemical structure.

Dainippon Sumitomo Pharma is a top-ten listed pharmaceutical company in Japan with a diverse portfolio of pharmaceutical, animal health and food and specialty products.