Dainippon Sumitomo Pharma America has announced that the US Food and Drug Administration (FDA) has accepted for review a New Drug Application for lurasidone to treat acute schizophrenia.
Lurasidone is an atypical antipsychotic agent with a unique chemical structure, which has high affinity for dopamine D(2), serotonin 5-HT(2A) and serotonin 5HT(7) receptors where it has antagonist effects.
Data submitted in the application includes evidence from more than 40 clinical studies involving more than 2,500 lurasidone-treated patients.
In all studies lurasidone demonstrated significantly greater improvement versus placebo on the primary efficacy measure, the positive and negative syndrome scale.
In all five studies, lurasidone was well tolerated and associated with limited weight gain or changes in metabolic parameters.
Schizophrenia is a chronic, disabling and serious medical illness that affects between two and three million American adults and more than 24 million adults worldwide.