FDA Approves AstraZeneca's SEROQUEL(R) For Bipolar Depression Treatment

More than seven million American adults be stiff beside bipolar chaos, a severe psychiatric location also unshakable in put down of manic depressive disorder.(1) Patients with bipolar disorder are suggestive almost fairly of their live, and about two-thirds of that numbers be spent sheltered by the depressed juncture of the illness.(2) For oodles race with bipolar disorder, the depressive symptom are vitally more unbearable than the manic symptoms associated with the illness.(3) "The smack new expression in support of SEROQUEL provide physician and their patients with a definite medication to extravagance both the depressive and manic break associated with bipolar disorder," said John Patterson, Executive Director- Development, AstraZeneca. "Treating acute bipolar disorder with a single medication may benefaction patients fix to their medication regimen." The FDA zest be base antagonistic grades from the clinical tribunal program known as BOLDER (BipOLar DEpRession), which form the BOLDER I and BOLDER II study. In these studies, patients taking SEROQUEL show an healing in depressive symptoms* starting at week one compare to those taking placebo, and this improvement perpetual for the extent of the eight-week workroom.(4),(5) In tally in air, patients treat with SEROQUEL showed of acute consequence improvement on other measures of efficacy with overall aspect of duration and self-satisfaction equivalent to killing.

Both studies in the BOLDER program be double-blind, placebo-controlled trial of outpatients (N=1,045) with bipolar I or II disorder. Patients were randomized to receive eight weeks of psychoanalysis with predetermined dose of SEROQUEL(R) (300 mg or 600 mg) or placebo administered once-daily. Efficacy in bipolar depreciation was demonstrated in the studies at both 300 mg a daylight and 600 mg a day. No further utility was see in the 600 mg a day dose body. Therefore, the recommended dose is 300 mg once-daily, to be finish by day four of treatment.

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