Healthcare Industry News:  BOLDER II 

Biopharmaceuticals FDA

 News Release - January 3, 2006

AstraZeneca Submits sNDA for SEROQUEL(R) for Bipolar Depression Treatment

Filing Seeks Approval of SEROQUEL as a Monotherapy Treatment for Bipolar Depression

ALDERLEY PARK, England, Jan. 3 (Healthcare Sales & Marketing Network) - AstraZeneca today announced submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) to seek approval for a new indication for SEROQUEL(R) (quetiapine fumarate) for the treatment of patients with depressive episodes associated with bipolar disorder. SEROQUEL is currently approved for the treatment of acute manic episodes associated with bipolar I disorder and the treatment of schizophrenia.

"AstraZeneca is dedicated to improving patients' lives and developing new treatments for mental illness," said Wayne Macfadden, MD, US Medical Director for SEROQUEL. "This sNDA submission is an important milestone in the history of SEROQUEL. If SEROQUEL receives approval from the FDA to treat bipolar depression, it would be the only single agent indicated to treat both the depressive and manic episodes associated with bipolar disorder."

The sNDA submission is based on results from the clinical trial programme known as BOLDER (BipOLar DEpRession), which comprises two studies: BOLDER I and BOLDER II. Both studies were double-blind, placebo-controlled trials of outpatients (N(equal sign)1,045) with bipolar I or II disorder. Patients were randomised to receive eight weeks' treatment with fixed doses of SEROQUEL (300 mg or 600 mg) or placebo administered once daily. In both studies, patients receiving SEROQUEL, as compared to those receiving placebo, showed a statistically significant decrease in depression scores at week one, and scores continued to decrease throughout the eight-week study. More than half of the SEROQUEL treated patients in each trial met the criteria for remission.(1)

Additionally, SEROQUEL was shown to have similar safety profiles in both BOLDER I and II. The most common adverse effects reported in these trials included dry mouth, sedation, somnolence, dizziness, and constipation.(1)

Bipolar disorder, which affects more than seven million American adults(2), consists of recurring episodes of mania and depression. Patients with bipolar disorder are symptomatic almost half of their lives, and approximately two-thirds of that time is spent in the depressed phase of the illness.(3) Prolonged periods of sadness, unexplained loss of energy, persistent lethargy, and recurring thoughts of death or suicide characterise depressive episodes.(4) Up to 50 per cent of patients with bipolar depression attempt suicide, and approximately 10 to 15 per cent commit suicide.(5) Furthermore, bipolar disorder is often misdiagnosed, and patients may suffer up to 10 years before a correct diagnosis is made.(6)

SEROQUEL(R) (quetiapine fumarate) is the number one prescribed atypical antipsychotic in the United States(7) and has a well-established safety and efficacy profile. In 2004, sales for SEROQUEL reached US$2 billion. SEROQUEL has had more than 13 million patient exposures worldwide since its launch in 1997.


Bipolar I disorder consists of recurring episodes of mania with or without depression. Bipolar II disorder consists of recurring episodes of depression and hypomania, a milder form of mania(8). In the long term, patients with bipolar I disorder spend three times longer in the depressed state than in mania. Patients with bipolar II disorder have traditionally been difficult to treat as they spend almost 40 times longer in the depressed state than in mania.(9) Without appropriate treatment, patients usually suffer for a lifetime with periods of wellness and functioning punctuated by severe episodes of illness. Both men and women are equally at risk for this illness, which most often emerges in adolescence or young adulthood and recurs throughout life.(8)

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Notes to Editors:

Depression scores were measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The MADRS scale measures the severity of a number of depressive symptoms including mood and sadness, tension, sleep, appetite, energy, concentration, and suicidal ideation.(10) The MADRS score decreases as depressive symptoms improve. Remission was defined as a MADRS score of less than or equal to 12. In BOLDER I, mean change in MADRS scores were at week eight from baseline (-)16.7 for SEROQUEL 600 mg and (-)16.4 for SEROQUEL 300 mg vs. (-)10.3 for placebo; (p less than 0.001). The corresponding mean changes in BOLDER II were (-)16.0, (-)16.9, and (-)11.9, respectively (p less than 0.001).


(1) Data on file, DA-SER-35

(2) Hirschfeld et al. Screening for Bipolar in the Community. J Clin Psychiatry. 2003;64:53-59.

(3) Judd LL, Akiskal HS, Schettler PJ, et al. The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry. 2002;59:530-537.

(4) Depression and Bipolar Support Alliance (DBSA), 730 N. Franklin Street, Suite 501, Chicago, Illinois 60610-7224. Introduction to Depression and Bipolar Disorder. Available at: Accessed December 7, 2005.

(5) Hawton, et al. Suicide and Attempted Suicide in Bipolar Disorder: A Symptomatic Review of Risk Factors. J Clin Psychiatry. 2005;66:693-704.

(6) Depression and Bipolar Support Alliance (DBSA). Facts About Bipolar Disorder. Accessed at Accessed December 7, 2005.

(7) All atypical prescriptions: Total prescriptions Jan 05 to Oct 05. New prescriptions Sept 04 to Oct 05 IMS Health. National Prescription Audit. (8) Kramlinger K. Mayo Clinic on Depression. Rochester, Minn.: Mayo Clinic Health Information, 2001.

(9) Calabrese JR, Keck PE, Macfadden W, et al, for the BOLDER Study Group. A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry. 2005;162;1351-1360.

(10) Lundbeck Institute. Psychiatric Rating Scales. PDF available at: Accessed December 7, 2005.

Source: AstraZeneca

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