View Full Version : Shire's EQUETRO(TM) Now Available for Treatment of Manic and Mixed Episodes in Bipola

04-21-05, 11:42 AM
BASINGSTOKE, England and PHILADELPHIA, April 19 /PRNewswire-FirstCall/ -- Shire Pharmaceuticals Group plc (LSE: SHP, Nasdaq: SHPGY, TSX: SHQ) announced today that EQUETRO(TM) (carbamazepine extended-release capsules), the only carbamazepine formulation proven effective for patients with Bipolar Disorder, is now available in the United States.

"The availability of carbamazepine extended-release capsules is a significant milestone in bipolar disorder therapy," said Richard H. Weisler, M.D., Adjunct Professor of Psychiatry at University of North Carolina at Chapel Hill School of Medicine, Adjunct Assistant Professor of Psychiatry and Behavioral Sciences at Duke University Medical Center, and primary investigator of two carbamazepine extended-release capsule clinical trials. "A lot of patients have trouble responding to bipolar medications, so a new treatment option means we can reach more people who suffer from bipolar disorder and help them restore balance in their lives."

Bipolar disorder causes unusual changes in mood - including overly "high" and/or irritable symptoms ("manic episodes"), and symptoms of depression. Some patients experience both manic and depressed symptoms at the same time ("mixed episodes").

EQUETRO has received FDA approval for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder. EQUETRO has been shown to significantly reduce manic symptoms in bipolar patients with manic and mixed episodes. In clinical trials,* patients treated with EQUETRO demonstrated a low incidence of clinically significant weight gain. The unique three-bead extended release delivery system of EQUETRO provides patients with smooth carbamazepine levels, and convenient administration. Patients take EQUETRO in twice-daily doses, which can be taken with or without food, and capsules may be opened and sprinkled onto soft food.

"Bipolar Disorder is a serious and debilitating psychological disorder that not only seriously affects patients, but also their family members and friends," said Matthew Emmens, Chief Executive of Shire. "We are pleased to bring this new choice of treatment to patients and hope that EQUETRO will help them to restore balance in their lives and improve quality of life."

Bipolar Disorder is one of the six leading mental disorders worldwide, according to the World Health Organization. More than two million American adults or about 1 percent of the population age 18 and older in any given year, are affected with Bipolar Disorder, also known as manic depression. The disorder is often not recognized as an illness, and as a result people may suffer for years before they are properly diagnosed and treated.