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FDA Approves Vanda Pharmaceuticals' Fanapt(TM) for the Treatment of Schizophrenia
Date:5/6/2009

psychiatrists in treating patients with schizophrenia. It is an effective antipsychotic with excellent tolerability," added Dr. Steven G. Potkin Professor of Psychiatry and Human Behavior at the University of California at Irvine. "We also look forward to Vanda's continuing development of long-acting formulations of Fanapt(TM), to further address the significant unmet medical issues in this population of patients."

"The approval of Fanapt(TM) by the FDA represents many years of tireless efforts by current and former colleagues, many investigators and thousands of patients who participated in the development of this new treatment for schizophrenia. I would like to extend my gratitude to all those who contributed and reaffirm the commitment of Vanda Pharmaceuticals to the discovery and development of medicines for those in need," said Mihael H. Polymeropoulos, MD, Vanda's Chief Executive Officer.

In a 4-week placebo-controlled trial (n=604) involving one fixed dose of Fanapt(TM) (24 mg/day) compared to placebo and an active control (Geodon(R)), the 24 mg/day Fanapt(TM) dose was superior to placebo in the Positive and Negative Syndrome Scale (PANSS) total score.

In a 6-week placebo-controlled trial (n=706) involving two dose ranges of Fanapt(TM) (12-16 mg/day and 20-24 mg/day) compared to placebo and an active control (Risperdal(R)), both doses of Fanapt(TM) were superior to placebo on the Brief Psychiatric Rating Scale (BPRS) total score.

While it is not known how long patients treated with Fanapt(TM) should be maintained on treatment, it is generally recommended that responding patients be continued beyond the acute response. Patients should be periodically reassessed to determine the need for maintenance treatment.

Fanapt(TM) was generally well-tolerated and the most commonly observed adverse reactions (incidence >= 5% and two-fold greater than placebo) were dizzines
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SOURCE Vanda Pharmaceuticals Inc.
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