Acute Mania - New bipolar disorder indication sought for Seroquel

27 января, 2003
AstraZeneca has announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration for Seroquel for the treatment of acute mania associated with bipolar disorder . Drug Week via NewsEdge Corporation : AstraZeneca has announced that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Seroquel (quetiapine) for the treatment of acute mania associated with bipolar disorder (manic-depressive illness). The application to the FDA follows the completion of a comprehensive bipolar disorder clinical trial program undertaken by AstraZeneca to examine the efficacy and tolerability of Seroquel in this important disease area. The program has delivered strong and positive results in both the monotherapy and adjunctive therapy studies, which confirm Seroquel to be an ideal first line agent in the treatment of acute mania associated with bipolar disorder. "Seroquel is destined to be an important treatment option for clinicians treating bipolar disorder," commented Gary Sachs from Harvard Medical School, Boston, and lead investigator on the studies. "Treatment compliance in bipolar disorder is particularly critical since patients may lead full and productive lives when stable while a relapse in symptoms can cause real difficulties. The ability of Seroquel to improve the symptoms of the disease while keeping side effects to a minimum, may improve quality of life and ultimately lead to greater compliance with medication, offering real benefits to clinicians, patients and families." The trial program consisted of 4 double-blind, randomized trials, involving almost 1000 patients in 28 countries. The trials assessed the effectiveness and safety of Seroquel as both monotherapy and adjunctive therapy with mood stabilizer in the treatment of acute mania associated with bipolar disorder. Results from 1 of the adjunct trials were presented at the 3rd European Stanley Foundation Conference in Bipolar Disorder, in Germany. The results from this 3-week trial showed that Seroquel (average dose in responders of 580 mg/day), in combination with a standard mood stabilizing medication (lithium or divalproex), is significantly more effective than mood stabilizers alone in treating acute mania and is also well tolerated. Specifically, the results showed that patients treated with Seroquel benefited from: * A significantly greater improvement from baseline in their Young Mania Rating Scale (YMRS) total scores at day 21 compared with patients taking mood stabilizers alone (-13.76 and -9.93 respectively, p=0.021). * A significantly greater improvement from baseline in their Clinical Global Impression Bipolar (CGI-BP) Severity of Illness scores at endpoint compared to patients taking mood stabilizer alone (-1.38 and -0.78 respectively, p=0.001). * An incidence of EPS no different from placebo across the full dose range. The results from the remaining monotherapy studies will be presented at major psychiatry conferences in 2003. "We are very pleased with the results of the trial program and are extremely optimistic about the future for Seroquel. Seroquel is a truly unique compound and its profile is ideal for the treatment of bipolar disorder," commented Geoff Birkett, global vice president, CNS, Pain, and Infection. "Success in the market is driven by the impact on patients and our vision to introduce therapies that truly change patients' lives for the better. With its expanded indication range, Seroquel will continue to help patients and is the cornerstone of our rapidly growing CNS business." Seroquel is manufactured by AstraZeneca and is currently approved in over 75 markets. Seroquel combines broad-based efficacy in the treatment of positive, negative, cognitive, and affective symptoms of schizophrenia, while offering excellent tolerability. Seroquel is associated with an incidence of EPS and prolactin elevation no different to placebo across the full dosage range, a favorable weight profile, and no clinically important effects on QT interval. To date, over 4 million people have been treated with Seroquel worldwide. This article was prepared by Drug Week editors from staff and other reports. <> << Copyright ©2003 NewsRx.com >>
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