Pfizer Obtains FDA Approval For Geodon Capsules

Published: 23-Nov-2009

For maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults

Pfizer has received FDA approval for Geodon (ziprasidone HCI) capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. The approval is based on clinical data demonstrating that Geodon is an effective and generally well-tolerated adjunctive treatment for long-term symptom control in patients with bipolar disorder.

Reportedly, the efficacy and safety of Geodon for the adjunctive maintenance treatment of bipolar disorder were studied in a six-month, double-blind, randomised, placebo-controlled trial in adult patients with bipolar I disorder.

In the study, after an open-label stabilisation period of 10 to 16 weeks, 240 patients were randomised to continue on Geodon plus lithium or valproate, or to have Geodon replaced by placebo. The primary endpoint in the study was time to recurrence of a mood episode requiring intervention.

The study result suggested that Geodon plus lithium or valproate was superior to placebo plus lithium or valproate in increasing the time to recurrence of a mood episode. During six months of treatment, 19.7% of patients in the Geodon arm required intervention for a mood episode, as compared to 32.4% of patients in the placebo arm.

However, the adjunctive Geodon treatment regimen was generally well-tolerated. Discontinuation due to adverse events occurred in 13% of patients in the placebo group, as compared to 9% of those in the Geodon group. The safety and tolerability data from this study are consistent with Geodon’s safety profile in adult patients, said the company.

Ilise Lombardo, senior medical director of specialty care at Pfizer, said: "The recurrence of mood episodes associated with bipolar disorder can have a devastating impact on patients’ lives. This approval underscores Pfizer’s commitment to supporting people suffering from serious mental health disorders.”

Tell your friend about this article