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New Worldwide Phase III Clinical Trials Examine Efficacy Of Seroquel In Treatment Of Symptoms Of Bipolar Disorder

AstraZeneca plans to launch three worldwide phase III clinical trials for its antipsychotic Seroquel in treating patients with bipolar disorder. The phase III clinical trials will determine the effectiveness of its atypical antipsychotic seroquel in the treatment of the symptoms of acute mania in patients with bipolar disorder. These trials will be conducted in addition to trial 99, a trial currently underway in the us to evaluate Seroquel therapy not only as adjunctive treatment, but also as monotherapy. Seroquel is indicated for the management of the manifestations of psychotic disorders as demonstrated by clinical trials in patients with schizophrenia.

Bipolar disorder is a mood disorder, one of several emotional disorders whose main symptom is a disturbance of mood.(1) Individuals with bipolar disorder experience disturbances in the regulation of mood.(1) The disorder, therefore, presents different symptoms at different times. Persons afflicted with bipolar disorder have periods of severe depression and periods of mania (elated, euphoric mood, irritability, impulsive behavior, grandiosity).(1) Current medical treatment for bipolar disorder typically includes a combination of mood-stabilizing medications, antidepressant medications and conventional antipsychotic medications which are often associated with side effects including tremors, shaking, zombie-like appearance, weight gain and sexual dysfunction.(2)

"A significant proportion of patients with bipolar disorder either does not respond or has difficulty tolerating currently available treatments; hence there is a greater need for investigating the usefulness of newer treatments such as Seroquel therapy" said Dr. Lakshmi Yatham, an Associate Professor of Psychiatry at the University of British Columbia in Vancouver, and head of the Canadian Network for Mood and Anxiety Treatment's (CANAMT) bipolar group. "These recently launched trials hold considerable promise for those who suffer from bipolar disorder. We are hopeful that these trials will further confirm that Seroquel is effective in treating the symptoms of bipolar disorder -- without causing the debilitating side effects often associated with current treatments."

These three double-blind, randomized trials will involve more than 800 patients in 28 countries with the objective of determining Seroquel therapy's efficacy and tolerability in a variety of clinical settings.

-- Trial 100 will evaluate Seroquel(r) (quetiapine fumarate) Tablets as an adjunctive treatment to a mood-stabilizing agent. The trial will involve 220 patients with acute manic episodes of bipolar disorder in over 30 centers across Western and Southern Europe, North America and Africa.

Trial 104 will compare the efficacy of Seroquel and haloperidol as monotherapy in acute mania in bipolar disorder compared to placebo. This study will include nearly 350 patients in 13 countries in Asia, Eastern Europe and South America.

Trial 105 will compare Seroquel therapy and lithium over placebo as monotherapy in the treatment of acute manic episodes in over 300 patients in Asia and Eastern Europe.

"Bipolar disorder touches countless families around the world -- which is why this global trial expansion is so encouraging," said Dr. Yatham. "What is particularly exciting is that we are investigating the option of using Seroquel not only as a combination treatment, but also as a monotherapy to relieve manic symptoms."

In studies supporting the approval of Seroquel, there were no differences from placebo across the clinical dose range in the incidence of EPS, including rigidity and difficulty starting and stopping movement, or in elevation of plasma prolactin levels. In addition, studies have shown that Seroquel exhibits a low incidence of hormonal, reproductive system (sexual dysfunction), and anticholinergic side effects (dry mouth, constipation).

The efficacy and atypical profile of Seroquel is supported by several placebo-controlled Phase II and III clinical trials in patients hospitalized for acute exacerbation of chronic or subchronic schizophrenia. Seroquel was well tolerated by more than 4,000 male and female patients 18 years and older in these trials. No blood monitoring is required.

In clinical trials, efficacy was demonstrated in a dose range of 150 mg/day to 750 mg/day. An initial target dose range of 300-400 mg can be given in two divided doses daily. The drug is manufactured in the United States by AstraZeneca and is available by prescription in strengths of 25-mg, 100-mg, 200-mg and 300-mg tablets. Since its approval in September of 1997, there have been more than 2.4 million prescriptions written for Seroquel for more than 623,000 patients in the United States.(3)(4)

As with other agents in its class, the labeling for Seroquel(r) (quetiapine fumarate) Tablets includes a warning relative to a rare condition known as tardive dyskinesia (which is often associated with long-term use of antipsychotic agents) and neuroleptic malignant syndrome (NMS symptoms include muscle rigidity, fever, and irregular pulse). Labeling precautions include orthostatic hypotension and the possible risk of cataract development. As with other antipsychotics, therapy with Seroquel should be used cautiously in patients with a history of seizures or with conditions that can potentially lower the seizure threshold. The most common adverse events associated with the use of Seroquel are dizziness (10%), postural hypotension (7%), dry mouth (7%), and dyspepsia (6%) and the majority of events are rated mild or moderate.

The safety and effectiveness of Seroquel in pediatric patients have not been established.

(1) Mondimore, F.M. Bipolar Disorder, A Guide for Patients and Families. Baltimore: The Johns Hopkins University Press, 1999. (2) Weiden P, Scheifler P, Diamond R, Ross R. Breakthroughs in Antipsychotic Medications. New York: W.W. Norton & Company, 1999. (3) Source(tm) Prescription Audit (SPA) 32-Month Period Ending June 2000. Scott Levin, a division of PMSI Scott-Levin, Inc. (4) NDC Health Information Services, Quetiapine Fumarate Patient Tracking Analysis. 31-Month Period Ending June 2000.

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