Pfizer's Geodon (ziprasidone HCl) was an effective and generally well-tolerated adjunctive treatment to mood stabilizers for the maintenance treatment of bipolar disorder, according to a new study presented earlier this week at the European Psychiatric Association's European Congress of Psychiatry. Ziprasidone is available in Europe and other markets under the trade name Zeldox.
"Patients with bipolar disorder taking a mood stabilizer often have breakthrough mood episodes," said study author Eduard Vieta, professor of Psychiatry, University of Barcelona, Spain. "These results demonstrate that ziprasidone was an effective adjunctive treatment for bipolar disorder over the long-term."
Bipolar disorder is a serious psychiatric disorder estimated to affect nearly 6 million Americans and nearly 30 million people worldwide. Pfizer filed an application with the US Food and Drug Administration (FDA) for an adjunctive bipolar maintenance indication for Geodon based on the results of this study.
The study, presented at ESA January 25, demonstrated the efficacy and safety profile of Geodon over the long-term, having met the primary endpoint of time to intervention for a mood episode. Over the course of six month's treatment, significantly fewer patients (19.7 per cent) taking Geodon plus a mood stabilizer (lithium or valproic acid) required intervention for a mood episode, compared to patients taking placebo plus a mood stabilizer (32.4 per cent).
Geodon was generally well-tolerated with fewer patients in the Geodon group (12.6 percent) discontinuing due to adverse events compared to the placebo group (14.3 percent).
Geodon is an atypical antipsychotic indicated in the United States for the management of symptoms of schizophrenia and acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features.