FDA approves atypical antipsychotic Geodon for treatment of acute bipolar mania, without major weight gain

FDA approves atypical antipsychotic Geodon for treatment of acute bipolar mania, without major weight gain

NEW YORK, N.Y., August 23, 2004 -- Pfizer announced that the FDA has approved the use of its atypical antipsychotic Geodon (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.

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.

According to a survey conducted by Harris Interactive 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. 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.

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 www.geodon.com

Source: Pfizer www.pfizer.com

Posted: August 2004


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