Dainippon Sumitomo Pharma America, a US subsidiary of Japan's Dainippon Sumitomo Pharma has submitted a new drug application to the US Food and Drug Administration (FDA) for lurasidone, an atypical antipsychotic agent for the treatment of schizophrenia.
The application, submitted on 30 December 2009, was based on positive data from more than 40 clinical studies involving more than 2,500 lurasidone-treated patients.
The four six-week, placebo-controlled studies, which included the global PEARL 1 and PEARL 2 clinical trials, demonstrated good tolerability with limited weight gain or changes in metabolic parameters as well as mild changes in movement disorder parameters and prolactin levels.
Dainippon Sumitomo Pharma president and chief executive officer Masayo Tada said that the company had 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," Tada said.
Lurasidone is an atypical antipsychotic with a unique chemical structure with high affinities for dopamine D(2), serotonin 5-HT(7), 5-HT(2A), 5-HT(1A), and noradrenaline alpha(2C) receptors and minimal-to-no affinity for histamine H(1) or cholinergic M(1) receptors.