FDA Approves Pfizer's atypical antipsychotic Geodon(R) for the Treatment of Acute Bipolar Mania

Geodon Is Not Associated With Significant Weight Gain, a Key Problem With

Other Treatments - Newly Released Survey Shows Patients Gain Up to 100 Pounds

on Current Bipolar Medications



Aug 23, 2004, 01:00 ET from Pfizer Inc

    NEW YORK, Aug. 23 /PRNewswire/ -- Pfizer Inc announced today that the U.S.
 Food and Drug Administration (FDA) has approved the use of its atypical
 antipsychotic Geodon(R) (ziprasidone HCI) for the treatment of acute bipolar
 mania including manic and mixed episodes.
     Prompt and effective control of acute mania is an important goal as
 patients are at an increased risk for impulsive and dangerous behaviors, often
 requiring psychiatric hospitalization. Geodon was shown to rapidly improve
 acute manic symptoms and to sustain these improvements over a three-week study
 period. Consistent with Geodon's overall clinical profile, no significant
 adverse effects on weight gain or lipids were seen.
     "With its rapid control of symptoms and favorable weight profile, Geodon
 provides an important new option for people suffering from bipolar mania,"
 said Dr. Joseph Feczko, president of Worldwide Development at Pfizer.
     In two randomized double-blind trials involving 416 hospitalized patients
 with acute bipolar mania, Geodon-treated patients showed greater improvement
 compared with placebo from day two through the end of the trial (day 21).
 Patients treated with Geodon were started on 80 mg per day with an increase
 permitted to 160 mg on day two in the first study and day three in the second
 study.
     Efficacy was measured using standardized psychiatric assessment scales.
 The most common adverse effects in the studies were somnolence, dizziness, and
 extrapyramidal symptoms.
 
     About the Survey
     According to a survey conducted by Harris Interactive(R) of 554 bipolar
 patients in the U.S. over the age of 30, seven out of ten have gained weight
 -- on average 50 pounds with one in ten gaining an alarming 100 pounds or more
 -- while taking bipolar medications. This medication-induced weight gain
 caused almost half of patients surveyed to stop taking or change their
 medication.
     More than one third of patients (39%) surveyed who had gained weight while
 on bipolar medications reported developing high cholesterol and three out of
 ten developed high triglycerides. Some even reported having other serious
 conditions including diabetes (13%) and abnormal lipid levels (18%).
     Despite the serious consequences that bipolar patients may experience when
 not properly treated, the majority (67%) say that they are unwilling to take a
 medication that controls symptoms but could cause them to gain 10 pounds or
 more.  Patients staying on their medication is key to reducing physician
 office visit and expense hospitalization.
     "Many bipolar medications cause substantial weight gain, making it
 challenging to treat patients for this serious and often disabling condition,"
 said Dr. Paul E. Keck, professor of psychiatry and pharmacology and vice
 chairman for research, Department of Psychiatry, University of Cincinnati
 College of Medicine. "Managing the symptoms of this disorder is the primary
 objective of treatment -- finding an agent that is acceptable to patients is
 also a key element to successful treatment. Geodon has now been proven to
 rapidly control the symptoms of acute bipolar mania and has not been
 associated with significant weight gain."
     Weight gain may be one reason that the patients surveyed have tried on
 average six medications to satisfactorily treat their bipolar disorder. In
 fact, one out of six bipolar patients has taken 11 or more medications seeking
 relief from their troubling condition that impacts their ability to function
 in daily life.
     It is important to note that patients should not discontinue their
 medication without consulting their physician first. With appropriate
 diagnosis and treatment, most patients can improve substantially and even
 resume normal functioning.
     Bipolar disorder, also referred to as manic-depressive illness, is a
 common and persistent psychiatric condition. Patients suffer from profound
 mood swings ranging from severe depression to unnatural 'highs." During manic
 periods, which can last for a week or more, patients may appear to be overly
 energetic, irritable, extremely talkative or excessively happy.
 
     About Geodon
     Approved in the United States in February of 2001 for the treatment of
 schizophrenia and in 2004 for acute bipolar mania, Geodon is licensed in
 67 countries, and more than three million prescriptions have been written
 worldwide. It is widely accepted on hospital, Medicaid, national VA and
 managed care formularies.
     Geodon is contraindicated in patients with a known history of QT
 prolongation, recent acute myocardial infarction, or uncompensated heart
 failure, and should not be used with other QT-prolonging drugs. Geodon has a
 greater capacity to prolong the QTc interval than several antipsychotics. With
 some drugs, QT prolongation has been associated with torsade de pointes, a
 potentially fatal arrhythmia.
     Hyperglycemia related adverse events, sometimes serious, have been
 reported in patients treated with atypical antipsychotics. There have been few
 reports of hyperglycemia or diabetes in patients treated with Geodon, and it
 is not known if Geodon is associated with these events.  Patients treated with
 an atypical antipsychotic should be monitored for symptoms of hyperglycemia.
     Full Geodon prescribing information is available at http://www.geodon.com.
 
 

SOURCE Pfizer Inc
    NEW YORK, Aug. 23 /PRNewswire/ -- Pfizer Inc announced today that the U.S.
 Food and Drug Administration (FDA) has approved the use of its atypical
 antipsychotic Geodon(R) (ziprasidone HCI) for the treatment of acute bipolar
 mania including manic and mixed episodes.
     Prompt and effective control of acute mania is an important goal as
 patients are at an increased risk for impulsive and dangerous behaviors, often
 requiring psychiatric hospitalization. Geodon was shown to rapidly improve
 acute manic symptoms and to sustain these improvements over a three-week study
 period. Consistent with Geodon's overall clinical profile, no significant
 adverse effects on weight gain or lipids were seen.
     "With its rapid control of symptoms and favorable weight profile, Geodon
 provides an important new option for people suffering from bipolar mania,"
 said Dr. Joseph Feczko, president of Worldwide Development at Pfizer.
     In two randomized double-blind trials involving 416 hospitalized patients
 with acute bipolar mania, Geodon-treated patients showed greater improvement
 compared with placebo from day two through the end of the trial (day 21).
 Patients treated with Geodon were started on 80 mg per day with an increase
 permitted to 160 mg on day two in the first study and day three in the second
 study.
     Efficacy was measured using standardized psychiatric assessment scales.
 The most common adverse effects in the studies were somnolence, dizziness, and
 extrapyramidal symptoms.
 
     About the Survey
     According to a survey conducted by Harris Interactive(R) of 554 bipolar
 patients in the U.S. over the age of 30, seven out of ten have gained weight
 -- on average 50 pounds with one in ten gaining an alarming 100 pounds or more
 -- while taking bipolar medications. This medication-induced weight gain
 caused almost half of patients surveyed to stop taking or change their
 medication.
     More than one third of patients (39%) surveyed who had gained weight while
 on bipolar medications reported developing high cholesterol and three out of
 ten developed high triglycerides. Some even reported having other serious
 conditions including diabetes (13%) and abnormal lipid levels (18%).
     Despite the serious consequences that bipolar patients may experience when
 not properly treated, the majority (67%) say that they are unwilling to take a
 medication that controls symptoms but could cause them to gain 10 pounds or
 more.  Patients staying on their medication is key to reducing physician
 office visit and expense hospitalization.
     "Many bipolar medications cause substantial weight gain, making it
 challenging to treat patients for this serious and often disabling condition,"
 said Dr. Paul E. Keck, professor of psychiatry and pharmacology and vice
 chairman for research, Department of Psychiatry, University of Cincinnati
 College of Medicine. "Managing the symptoms of this disorder is the primary
 objective of treatment -- finding an agent that is acceptable to patients is
 also a key element to successful treatment. Geodon has now been proven to
 rapidly control the symptoms of acute bipolar mania and has not been
 associated with significant weight gain."
     Weight gain may be one reason that the patients surveyed have tried on
 average six medications to satisfactorily treat their bipolar disorder. In
 fact, one out of six bipolar patients has taken 11 or more medications seeking
 relief from their troubling condition that impacts their ability to function
 in daily life.
     It is important to note that patients should not discontinue their
 medication without consulting their physician first. With appropriate
 diagnosis and treatment, most patients can improve substantially and even
 resume normal functioning.
     Bipolar disorder, also referred to as manic-depressive illness, is a
 common and persistent psychiatric condition. Patients suffer from profound
 mood swings ranging from severe depression to unnatural 'highs." During manic
 periods, which can last for a week or more, patients may appear to be overly
 energetic, irritable, extremely talkative or excessively happy.
 
     About Geodon
     Approved in the United States in February of 2001 for the treatment of
 schizophrenia and in 2004 for acute bipolar mania, Geodon is licensed in
 67 countries, and more than three million prescriptions have been written
 worldwide. It is widely accepted on hospital, Medicaid, national VA and
 managed care formularies.
     Geodon is contraindicated in patients with a known history of QT
 prolongation, recent acute myocardial infarction, or uncompensated heart
 failure, and should not be used with other QT-prolonging drugs. Geodon has a
 greater capacity to prolong the QTc interval than several antipsychotics. With
 some drugs, QT prolongation has been associated with torsade de pointes, a
 potentially fatal arrhythmia.
     Hyperglycemia related adverse events, sometimes serious, have been
 reported in patients treated with atypical antipsychotics. There have been few
 reports of hyperglycemia or diabetes in patients treated with Geodon, and it
 is not known if Geodon is associated with these events.  Patients treated with
 an atypical antipsychotic should be monitored for symptoms of hyperglycemia.
     Full Geodon prescribing information is available at http://www.geodon.com.
 
 SOURCE  Pfizer Inc

RELATED LINKS

http://www.pfizer.com