Posted by Phillipa on November 24, 2009, at 21:22:28
Thought this might be of interest. Phillipa
From Medscape Medical News > Alerts, Approvals and Safety Changes > FDA Approvals
FDA Approves Ziprasidone for Maintenance Treatment of Bipolar Disorder
Yael Waknine
Click here November 23, 2009 The US Food and Drug Administration (FDA) has approved an expanded indication for the atypical antipsychotic ziprasidone HCl (Geodon capsules, Pfizer, Inc), allowing its use as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder in adults."The FDA approval of Geodon provides an additional treatment option for patients with bipolar disorder, who require maintenance therapy to keep the symptoms of the disease under control," said Charles Bowden, MD, clinical professor of psychiatry and pharmacology at University of Texas Health Science Center, San Antonio, in a company news release. With a prevalence of more than 90%, recurrent mood episodes are linked to a high rate of disability that can have a devastating effect on patients' lives.
Approval of the indication was based on data from a double-blind, placebo-controlled trial of 240 stabilized patients showing that the addition of ziprasidone to mood stabilizers significantly delayed time to recurrence of a mood episode. Only 19.7% of patients receiving combination therapy required intervention for a mood episode during the 6-month period compared with 32.4% of those receiving lithium or valproate alone.
Add-on ziprasidone therapy was generally well-tolerated in the study; tremor was the only adverse event occurring more frequently than with lithium or valproate alone (6.3% vs 3.6%). Other ziprasidone-related effects may include somnolence, extrapyramidal symptoms, dizziness, akithisia, and abnormal vision.
Ziprasidone was previously approved for the acute treatment of manic/mixed bipolar episodes and schizophrenia.
poster:Phillipa
thread:926892
URL: http://www.dr-bob.org/babble/20091117/msgs/926892.html