Pfizer Inc has submitted a supplemental new drug application with the U.S. Food and Drug Administration to support the approval of its psychotropic medicine Geodon (ziprasidone HCl) for the treatment of acute bipolar mania.
Bipolar disorder, also known as manic-depressive illness, is a common and serious psychiatric disorder that is estimated to affect nearly four in every 100 Americans. Patients suffer from severe mood swings ranging from persistent depression to elevated mood states.
The submission is supported by two randomized, double-blind, placebo-controlled studies that involved 415 patients diagnosed with acute bipolar mania. The two trials examined the efficacy, safety and tolerability of Geodon.
Results from both trials consistently demonstrated that treatment with Geodon was superior to placebo in improving manic symptoms and overall illness severity. Based on results from the Mania Rating Scale, the primary assessment tool, improvement was seen by day two for patients treated with Geodon. "Geodon is a well-tolerated treatment option that works quickly to improve troublesome symptoms such as extreme excitement, hyperactivity, and delusional behavior," said Dr. Steven Potkin, professor of psychiatry, University of California at Irvine. "This is critical for patients who are often unable to function in daily life during these manic episodes."
Geodon-treated patients in both studies began taking 80 mg on day one, 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.
Discovered and developed by Pfizer, Geodon is a serotonin and dopamine antagonist. The FDA approved the medicine in February 2001 for use in the treatment of schizophrenia.
In short-term trials, the most commonly observed side effects associated with Geodon at an incidence of greater than or equal to 5 percent and at least twice the rate of placebo were somnolence (14 percent vs. 7 percent), respiratory distress (8 percent vs. 3 percent), of which more than 90 percent were cold symptoms or upper respiratory infections, and EPS (5 percent vs. 1 percent).
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.