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FDA approves Pfizer's bipolar treatment

The FDA has approved Pfizer's Geodon capsules as an adjunct to lithium or valproate as a maintenance treatment for bipolar I disorder in adults

The US Food and Drug Administration (FDA) has approved Pfizer's Geodon (ziprasidone HCI) capsules as an adjunct to lithium or valproate as a maintenance treatment for bipolar I disorder in adults.

Geodon's safety and efficacy were tested during a six-month, double-blind, randomised, placebo-controlled trial in adults with bipolar I disorder. Clinical data showed the drug to be effective as a well tolerated long-term treatment to control symptoms of bipolar disorder in adults.

During six months of treatment, 19.7 per cent of patients who received Geodon required intervention for a mood episode, compared with 32.4 per cent of patients who received the placebo.

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

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

23rd November 2009

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