Geodon approved for adjunctive maintenance treatment of bipolar I disorder

The FDA has approved Geodon (ziprasidone HCl, from Pfizer) capsules for the maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. This approval was based on data from a six-month, double-blind, randomized, placebo-controlled trial that demonstrated 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 who received Geodon required intervention for a mood episode, compared with 32.4% of patients who received placebo.

Geodon is already approved for the treatment of acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for the treatment of schizophrenia.

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