21st Oct 2005 07:01
AstraZeneca PLC21 October 2005 BOLDER II STUDY CONFIRMS THERAPEUTIC POTENTIAL OF SEROQUEL IN BIPOLAR DEPRESSION Newly released top-line results from the BOLDER II (BipOLar DEpRession) studyhave underlined the potential for SEROQUEL (quetiapine fumarate) in thetreatment of patients with major depressive episodes associated with bipolardisorder. Based on prior discussions with the US Food and Drug Administration(FDA) and the results of BOLDER II, AstraZeneca plans to file for a US licenceextension for SEROQUEL in the treatment of depressive episodes associated withbipolar disorder around the end of this year (2005). BOLDER II - an eight week, multi-centre, placebo-controlled study - found thatSEROQUEL 300mg and 600mg doses achieved a statistically significant reduction inlevels of bipolar depression compared with placebo (p-value less than or equalto 0.001), as measured by the change from baseline in Montgomery-AsbergDepression Rating Scale (MADRS) total score. The significant reduction in MADRS total score was seen both in patients withbipolar I and bipolar II disorder, in patients with or without a rapid cyclingcourse of illness, and as early as week one after randomisation. Significantimprovements were also seen compared with placebo in the various secondary studyendpoints among SEROQUEL-treated patients, including reduction of anxietysymptoms. In addition, more than half (53 per cent) of patients receivingSEROQUEL achieved remission from their bipolar depression symptoms. BOLDER II reinforces the findings of the landmark BOLDER I study published inAmerican Journal of Psychiatry in July 2005, which first indicated a significanteffect for SEROQUEL in treating major depressive episodes associated withbipolar disorder. Importantly, SEROQUEL was shown to be well tolerated inBOLDER II with a similar safety profile seen to that in BOLDER I. The rate ofserious adverse events was low, and comparable in all treated groups. The mostcommon adverse events reported in the trial were dry mouth, sedation,somnolence, dizziness and constipation. There was a low incidence oftreatment-emergent mania in the SEROQUEL-treated groups. As in BOLDER I, therewas a low incidence of EPS (extrapyramidal symptoms) and minimal weight changereported in the study. Patients with bipolar depression are underserved and understudied. The findingsfrom the BOLDER II study are very encouraging and support the findings of BOLDERI, in showing the potential of SEROQUEL, as monotherapy, for the acute treatmentof bipolar depression. Each of these two studies represent the largestplacebo-controlled short-term studies ever conducted in bipolar depression. Thebeneficial risk:benefit profile of Seroquel seen in both studies could offer animportant therapeutic value for both patients and physicians as there iscurrently only one FDA approved therapy to treat depressive episodes associatedwith bipolar disorder. Bipolar disorder is a serious mental illness that affects approximately 3-4 percent of the adult population and is the sixth leading cause of disability in theworld. Patients with bipolar disorder are symptomatic almost half of theirlives, and approximately two-thirds of that time is spent in the depressed phaseof the illness. SEROQUEL has been licensed for the treatment of schizophrenia since 1997 and isavailable in 85 countries for the treatment of this condition. It is currentlylicensed for the treatment of mania associated with bipolar disorder in 73countries. In the first half of 2005, SEROQUEL sales reached $1,300 million. - Ends - 21st October 2005 Media Enquiries:Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033 Investor Enquiries:Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087Ed Seage, Tel: +1 302 886 4065Jorgen Winroth, Tel + 1 212 579 0506 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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