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Back To Vidyya First-Line Therapy For Schizophrenia Clears Committee

FDA Advisory Committee Recommends Approval For Pfizer's Zeldox®

Pfizer Inc. said today that an Advisory Committee to the U.S. Food and Drug Administration (FDA) recommended approval of Zeldox® (ziprasidone HCl) for the treatment of schizophrenia.

Discovered and developed by Pfizer, Zeldox® is a serotonin and dopamine antagonist that is effective in treating the wide range of positive, negative and depressive symptoms associated with schizophrenia. Positive symptoms include visual and auditory hallucinations and delusions. The harder-to-treat negative symptoms include blunted affect, social withdrawal and lack of motivation.

Schizophrenia is a chronic illness that requires lifelong treatment. It affects approximately one percent of the world's population and is estimated to cost more than $104 billion in hospital costs, medications, health care services and lost productivity.

The 4,500 patient worldwide clinical trials program was the largest ever conducted for a novel antipsychotic medicine prior to launch. In addition to its demonstrated efficacy in treating schizophrenia, Zeldox® was demonstrated to be weight neutral, a feature that distinguishes it from all marketed atypical antipsychotics. Significant weight gain, associated with many currently available antipsychotic medicines, is distressing and stigmatizing to patients and often results in non-compliance. Patients who gain weight may also be at greater risk for cardiovascular complications such as increased lipid levels and poor glycemic control.

Clinical trial data also showed that Zeldox® was associated with a low incidence of abnormal movements and sexual dysfunction. Additionally, Zeldox® patients in a 52-week study had a significantly reduced risk of relapse. Management of schizophrenia is complicated by high rates of relapse.

In addition to recommending approval, the various committee members who commented expressed their opinion that Zeldox® should be approved for first line therapy, but should be labeled to provide adequate information to physicians and patients as to the effects of the drug on the QTc interval of the electrocardiogram.

The most common side effects reported in persons treated with Zeldox® in clinical trials included headache, somnolence, nausea, constipation and dyspepsia. These side effects were generally of mild to moderate severity and rarely led to discontinuation of the drug.

Pfizer said that it anticipates working closely with FDA as Zeldox® progresses through the Agency's final review and labeling stages. Pfizer also said that it plans to introduce Zeldox® in Sweden in September and proceed with the mutual recognition process in Europe. Zeldox has been approved in Brazil, Venezuela, New Zealand and the Czech Republic.

Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines, for humans and animals, and many of the world's best-known over-the-counter brands. This year, Pfizer expects global sales of more than $31 billion and has a research and development budget of $4.7 billion.

Information from Pfizer, Inc., available at their Web site

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Editor: Susan K. Boyer, RN
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