Equetro OK'd for Bipolar Disorder
Patient trials showed little blood glucose change
MONDAY, Dec. 13, 2004 (HealthDayNews) -- The U.S. Food and Drug Administration has approved the Shire Pharmaceuticals drug Equetro (extended release carbamazepine) for acute manic episodes associated with bipolar disorder, the company announced Monday.
A Shire statement recounting patient trials said the drug produced no clinically significant weight gain or changes in blood glucose, two side effects of similar medications. Elevated blood glucose is a risk factor for diabetes.
Bipolar disorder, characterized by mood swings of mania and depression and periods of normal mood in between, affects some 2 million American adults annually, the company said. Also known as manic depression, the condition ranks among the top six mental disorders worldwide, Shire said, citing the World Health Organization.
The drug is expected to hit the U.S. market in the first quarter of 2005, the company said.
For more information about bipolar disorder, visit the National Institute of Mental Health.