Drug maker Pfizer Inc. (PFE), Friday said the U.S. health regulators' approved its mood disorder capsule Geodon as an adjunct with lithium for bipolar I 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," Pfizer said
The approval follows positive data from a six-month, placebo-controlled trial in 240 patients evaluating the activity of the drug plus lithium or valproate.
The primary end-point studied the 'time to recurrence of a mood episode' requiring intervention, a symptom considered to be prevalent in more than 90% patients with the disorder. Geodon proved superior to placebo in reducing the symptom.
Geodon was approved by FDA in February 2001, currently in-use for the treatment of acute manic and mixed episodes associated with bipolar disorder and for the treatment of schizophrenia. The drug earned $252 million in worldwide sales for Pfizer in third quarter, of which $210 million was from the U.S.
Bipolar disorder, also known as manic depressive disorder, affects approximately 5.7 million adults in the United States according to New York- based Pfizer. The disease is also associated with high rates of disability.
The day proved lucky for the drug giant, as the regulators also approved an Intravenous formulation of its Revatio, used to treat Pulmonary Arterial Hypertension.
PFE finished Friday's regular trading sessions at $18.36, gaining 25 cents on 52.88 million shares.
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