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Vanda Pharmaceuticals Receives FDA Acceptance of Iloperidone New Drug Application
Date:11/27/2007

ROCKVILLE, Md., Nov. 27 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced today that the U.S. Food and Drug Administration (FDA) has officially accepted the New Drug Application (NDA) for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia. Acceptance of the NDA confirms that the application is sufficiently complete for FDA review.

About Schizophrenia

Schizophrenia is a chronic, severe and disabling brain disorder that affects approximately one percent of Americans. Patients suffering from schizophrenia exhibit a range of symptoms, which include positive symptoms such as hallucinations, delusions, negative symptoms such as emotional withdrawal and cognitive symptoms associated with significant impairment in social and occupational functioning.

Unmet Needs in Schizophrenia

Although there are many drugs approved to treat schizophrenia, including the commonly prescribed "atypical antipsychotics," a high degree of dissatisfaction remains among physicians and patients. The recent CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) study, conducted by the National Institute of Mental Health (NIMH) and reported in The New England Journal of Medicine, evaluated several antipsychotic medications and revealed that 74% of patients taking antipsychotics discontinued treatment within 18 months, primarily because of insufficient efficacy and tolerability issues.

About Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Inc. is a biopharmaceutical company with a focus on the development and commercialization of clinical-stage product candidates for central nervous system disorders. The company has three product ca
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SOURCE Vanda Pharmaceuticals Inc.
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