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.
Go deeper with GlobalData
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalData
