ROCKVILLE, Md., Sept. 27 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia. The application includes data from 35 clinical trials and more than 3,000 patients treated with iloperidone.
Iloperidone has demonstrated efficacy in treating the symptoms of schizophrenia both in the acute and the chronic setting. Iloperidone's binding to a number of dopamine and serotonin receptors provides a favorable safety profile on adverse symptoms, such as weight gain, extrapyramidal symptoms, akathisia and prolactin elevation. The NDA submission also contains pharmacogenetic data aimed to further improve the benefit/risk profile of iloperidone in the treatment of patients with schizophrenia.
"The submission of the iloperidone NDA marks a significant milestone for Vanda. Iloperidone may become an important instrument in the treatment of patients with schizophrenia and may help to usher the field of psychiatry into an era of personalized medicine," said Mihael H. Polymeropoulos, M.D., President and CEO, Vanda Pharmaceuticals Inc.
"For a serious brain disorder like schizophrenia, which affects about
three million Americans in the prime of life, it is vital that new
pharmacotherapeutic agents be developed in light of the fact that existing
antipsychotic treatments work partially in some patients and not others,
leaving many patients continuously disabled. The NIMH-funded CATIE
effectiveness study revealed the efficacy or safety limitations of current
agents. Iloperidone is a new antipsychotic that c
|SOURCE Vanda Pharmaceuticals|
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