In a New Study Ziprasidone Demonstrated Fast Onset of Action in Significantly Reducing Symptoms of Acute Mania in Patients With Bipolar Disorder

Apr 04, 2003, 00:00 ET from Pfizer Inc

    NEW YORK, April 4 /PRNewswire-FirstCall/ -- Bipolar patients who received
 Pfizer Inc's atypical antipsychotic ziprasidone showed significant improvement
 in symptoms of acute mania compared with those who received placebo, according
 to data published today in the American Journal of Psychiatry.
     Results from this randomized, double-blind, placebo-controlled study
 demonstrated that ziprasidone produced rapid, sustained improvements in manic
 symptoms when compared to placebo.  Significant improvements were observed
 within two days of treatment and were maintained throughout the three-week
     The study, which involved 210 inpatients, also demonstrated that after
 7 days of treatment ziprasidone-treated patients showed significant
 improvement across all evaluation scales compared to those who took placebo,
 including symptoms of acute mania, psychosis and social functioning.
     "Physicians are often looking for effective treatment options to help
 control the multiple symptoms of acute mania in patients who suffer from
 bipolar disorder," said Dr. Paul Keck, Professor of Psychiatry and
 Pharmacology and Vice Chairman for Research, Department of Psychiatry,
 University of Cincinnati College of Medicine.  "This study suggests that
 ziprasidone may be a rapid and beneficial treatment option for bipolar mania."
     Bipolar disorder, which is also referred to as manic-depressive illness,
 is a serious form of mood disorder in which patients may experience extreme
 'highs,' or manic episodes, and extreme 'lows,' or periods of major
 depression.  The condition is estimated to affect one in every 100 Americans
 and has a major impact on the ability to function in daily life.  Bipolar
 disorder is estimated to cost society about $45 billion per year.
     Patients in the midst of a period of mania, which usually lasts at least a
 week, may appear to be overly energetic, extremely expansive or excessively
 happy.  They may have difficulty sleeping, functioning in social or work
 situations and may overindulge in pleasurable activities.
     The study was conducted in the United States and Brazil.  Ziprasidone
 patients began taking 80 mg per day and were quickly titrated to 160 mg per
 day by the second day. Dosing was then flexible for the remainder of the
 study.  Efficacy was measured using standardized psychiatric assessment
     Among ziprasidone-treated patients, there was a low incidence of movement
 disorders, a side-effect associated with some atypical antipsychotic
 medications and no clinically significant weight gain, changes in vital signs
 or other safety parameters.
     The most common side effects of ziprasidone in this study included
 somnolence, headache, dizziness, hypertonia, nausea and akathisia.
     Discovered and developed by Pfizer, ziprasidone is a serotonin and
 dopamine antagonist.  The medicine was approved by the U.S. Food and Drug
 Administration in February 2001 for use in the treatment of schizophrenia.  It
 also is approved in more than 45 countries worldwide.
     Ziprasidone received approval for the treatment of acute mania in Brazil
 in November 2002.  Pfizer plans to file a supplemental new drug application
 FDA later this year for the treatment of acute mania. Ziprasidone is currently
 marketed as Geodon in the United Sates and in Brazil.
     Oral ziprasidone is associated with a prolongation of the QTc interval of
 the electrocardiogram, an effect seen with certain other marketed medicines,
 including some antipsychotics.  This effect was well characterized in the
 extensive oral ziprasidone trials database and is reflected in the FDA's
 product labeling, which suggest that physicians use their best judgment as to
 whether ziprasidone is the appropriate medication based on the overall status
 of the patient.
     Pfizer Inc discovers, develops, manufactures and markets leading
 prescription medicines, for humans and animals, and many of the world's best
 known consumer products.

SOURCE Pfizer Inc