Equetro(TM) Now Available in US for Treatment of Manic and Mixed Episodes in Bipolar Disorder

Main Category: Bipolar
Article Date: 20 Apr 2005 - 15:00 PDT

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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.

About Bipolar Disorder

Bipolar Disorder is characterized by episodes of mania and depression, with periods of normal mood in between. The disorder can have devastating effects on an individual's life, although proper diagnosis and early treatment can usually alter the course of the illness.

Because of the severity of the illness, bipolar disorder is disruptive to patients, their families, friends and colleagues and can damage relationships, cause poor job or school performance and suicide. Although bipolar disorder is not curable, it is treatable and recovery is possible. Early diagnosis combined with drug therapy is key to optimal treatment.

Safety Information

EQUETRO(TM) contains carbamazepine. Please ensure patient is not taking any other form of carbamazepine.

The most frequently reported adverse events are dizziness, drowsiness, unsteadiness, nausea and vomiting. Initiating therapy at the lowest possible effective dose can minimize adverse events. Reports of transient or persistent decreased platelet or white blood cell count are not uncommon in association with the use of carbamazepine. Although the vast majority of cases of leukopenia have not progressed to the more serious conditions of aplastic anemia or agranulocytosis, complete pretreatment hematological testing should be obtained as a baseline. Patients should be monitored and discontinuation of the drug should be considered if any evidence of bone marrow depression occurs.

Because the possibility of a suicide attempt is inherent in bipolar disorder, close supervision of high-risk patients should accompany drug therapy.

Additional Information

EQUETRO was approved by the Food & Drug Administration on December 10, 2004 for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder. It is available in 100 milligram (mg), 200 mg and 300 mg dosage strengths. EQUETRO has a formulation patent that runs until 2011 and will have three years market exclusivity under the US Hatch-Waxman Act.

EQUETRO(TM) is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder.

*An analysis of pooled data from two nearly identically designed, three- week, double-blind, placebo-controlled phase III trials of EQUETRO monotherapy in patients initially requiring hospitalization. The trials involved 443 patients aged 18 to 76 with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV(R)) diagnosis of bipolar disorder (current episode manic or mixed) who were randomized to double-blind treatment with either EQUETRO or placebo.

The pooled analysis revealed that by the end of the trials, EQUETRO patients, both manic and mixed, experienced significant reductions in Young Mania Rating Scale total scores as well as significant improvements in Clinical Global Impression-Severity and Clinical Global Impression-Improvement scores. Investigators measured the safety and tolerability of EQUETRO by measuring participants' weight, blood glucose, cholesterol and interval between heartbeats, as well as adverse event monitoring. Dr. Weisler reported the pooled data analysis Nov. 18, 2004 at the 17th annual U.S. Psychiatric and Mental Health Congress in San Diego, California.

Shire Pharmaceuticals Group plc

Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US. For further information on Shire, please visit the Company's website: http://www.shire.com

THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward- looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization, the impact of competitive products, including, but not limited to, the impact of those on Shire's Attention Deficit & Hyperactivity Disorder (ADHD) franchise, patents, including but not limited to, legal challenges relating to Shire's ADHD franchise, government regulation and approval, including but not limited to Health Canada's suspension of ADDERALL XR sales in Canada and the expected product approval dates of methylphenidate transdermal system (MTS) (ADHD), SPD503 (ADHD), SPD 465 (ADHD), SPD 476 (ulcerative colitis), and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Agency in the United States, Shire's ability to secure new products for development, and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2004.

Shire Pharmaceuticals Group plc
http://www.shire.com

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