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
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 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
Information from Pfizer, Inc., available at their Web site http://www.pfizer.com