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News Release - May 22, 2006
New Studies Examine SEROQUEL(R) in Combination With Antidepressant Therapy in Patients With DepressionWILMINGTON, Del., May 22 (HSMN NewsFeed) -- AstraZeneca (NYSE: AZN ) today announced results of two clinical studies that examined SEROQUEL® (quetiapine fumarate) in combination with antidepressant therapy in patients with depression. One study evaluated the use of SEROQUEL in combination with antidepressant therapies (SSRI/SNRI medications(+)) to improve residual depressive and anxiety symptoms in patients with major depressive disorder.(1) Another study examined the benefit of SEROQUEL when added to SSRI/SNRI therapies in patients with treatment-resistant depression.(2) These two studies were presented at the annual meeting of the American Psychiatric Association (APA).
SEROQUEL is approved for the treatment of acute manic episodes associated with bipolar I disorder and the treatment of schizophrenia. On December 30, 2005, AstraZeneca submitted a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) to seek approval for SEROQUEL in the treatment of patients with depressive episodes associated with bipolar disorder. SEROQUEL is currently being investigated for the treatment of major depressive disorder.
"There is growing evidence that augmentation of antidepressant therapy with atypical antipsychotics may help improve symptoms of depression," said Greg Mattingly, M.D., Associate Clinical Professor, Department of Psychiatry, Washington University School of Medicine. "These studies are encouraging and warrant further investigation of the potential of SEROQUEL® (quetiapine fumarate), both as a monotherapeutic agent as well as in the augmentation of SSRI/SNRI therapy, in patients with major depressive disorder."
ABOUT THE STUDIES
One study was a double-blind, randomized placebo-controlled trial designed to evaluate SEROQUEL augmentation of SSRIs/SNRIs in patients with residual depressive and prominent anxiety symptoms associated with major depression. In this study, patients (n=58) with residual symptoms following at least six weeks of SSRI/SNRI treatment received SEROQUEL (50-600mg/day; mean dose=202 mg/day) or placebo for eight weeks.(1)
The study found significant reduction (SEROQUEL vs. placebo) in several rating scales as early as week 1 (p less than or equal to 0.01) and continuing through week 8 (p less than or equal to 0.01). HAM-D(++) results for SEROQUEL at week 1 and week 8 vs. placebo at week 1 and week 8 were -6.5 and -11.2 vs - 2.9 and -5.5; HAM-A (S) (-7.4, -12.5 vs -3.4, -5.9); CGI-Severity** (-0.45, -1.5 vs -0.07, -0.6).(1)
The second trial, also a randomized, double-blind, placebo-controlled trial (n=39), examined augmentation of SEROQUEL (200-400 mg/day; mean dose=268 mg/day) to SSRI/SNRI therapy in treatment-resistant depression. At the end of the eight-week trial, patients receiving SEROQUEL® (quetiapine fumarate) had significantly lower HAM-D17 scores versus placebo (8.3 vs. 14.7, respectively, p<0.01). Additionally, significantly more patients receiving SEROQUEL demonstrated a response to treatment (greater than or equal to 50% reduction in HAM-D17 score) (67% vs. 27%, p=0.015), and achieved remission (HAM-D17 score <7) (43% vs. 15%, p<0.05), versus placebo.(2)
The most common adverse events observed in these trials include sedation, somnolence, lethargy, dry mouth, weight gain, dizziness, headache, similar to previous clinical trials of SEROQUEL.(1,2)
"AstraZeneca recognizes the difficulties in treating depression and is dedicated to finding new therapies and regimens for patients who suffer from this disorder," adds Wayne Macfadden, M.D., US Medical Director for SEROQUEL. "The results of these analyses reinforce the importance of additional investigation of the potential role of SEROQUEL in managing symptoms associated with depression."
The studies were conducted by A. McIntyre and associates at the Department of Psychiatry of Penticton Regional Hospital in Penticton, British Columbia, Canada and Gregory W. Mattingly and associates at Washington University School of Medicine. Both studies were supported by AstraZeneca Pharmaceuticals.
SEROQUEL is the #1 prescribed atypical antipsychotic in the United States.(3) With a well-established safety and efficacy profile, SEROQUEL has had more than 16 million patient exposures worldwide since its launch in 1997. In 2005, global sales for SEROQUEL reached $2.8 billion.
IMPORTANT SAFETY INFORMATION
SEROQUEL® (quetiapine fumarate) is indicated for the treatment of acute manic episodes associated with bipolar I disorder, as either monotherapy or adjunct therapy with lithium or divalproex, and the treatment of schizophrenia. Patients should be periodically reassessed to determine the need for continued treatment. It is recommended SEROQUEL be taken twice daily in divided doses. SEROQUEL is not currently approved for the treatment of major depressive disorder or the depressive phase of bipolar disorder.
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). SEROQUEL is not approved for the treatment of patients with dementia-related psychosis.
Prescribing should be consistent with the need to minimize the risk of tardive dyskinesia. A rare condition referred to as neuroleptic malignant syndrome has been reported with this class of medications, including SEROQUEL.
Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including SEROQUEL. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.
Precautions include the risk of seizures, orthostatic hypotension, and cataract development.
The most commonly observed adverse events associated with the use of SEROQUEL in clinical trials for schizophrenia and bipolar mania were somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, SGPT increase, dyspepsia, and weight gain.
For full Prescribing Information for SEROQUEL, please visit the Web site http://www.seroquel.com.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. In the United States, AstraZeneca is a $10.77 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com
This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2005.
+Selective serotonin reuptake inhibitors (SSRIs) act specifically on the neurotransmitter serotonin. These medications include fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil), citalopram (Celexa) and escitalopram (Lexapro). Serotonin and norepinephrine reuptake inhibitors (SNRIs) are useful as first-line treatments in people taking an antidepressant for the first time and for people who have not responded to other medications. These medications include Venlafaxine (Effexor).(4) ++ Hamilton Depression Rating (HAM-D) Scale: This scale is used to assess the severity of depression in patients already diagnosed with an affective disorder. There are two versions of the scale using either 21 or 17 items (HAM-D21 and HAM-D17); the 17-item scale uses the first 17 questions on the full scale. Items are scored from 0 to 4, the higher the score, the more severe the depression. Questions are related to symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels and weight loss.(5) SHamilton Anxiety Rating (HAM-A) Scale: This scale consists of 14 items, each defined by a series of symptoms. The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptomatology. The scale measures the severity of symptoms such as anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, restlessness and other physical symptoms. Items are scored from 0 to 4, the higher the score, the more severe the symptoms. ** Clinical Global Impression (CGI) Scale: The CGI scale refers to the global impression of the patient and requires clinical experience with the syndrome under assessment. The CGI improvement scale can be completed only following or during treatment. The concept of improvement refers to the clinical distance between the individual's current condition and that prior to the start of treatment. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).
(1) A. McIntyre, A. Gendron, A. McIntyre. Quetiapine reduces residual depressive and prominent anxiety symptoms in partial responders to selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) with major depression: an 8-week, double-blind, randomised, placebo- controlled study. Annual Meeting of the American Psychiatric Association, 2006, Toronto, Canada, research poster board NR254. (2) G. Mattingly, H. Ilivicky, J. Canale, R. Anderson. Quetiapine Combination for Treatment-Resistant Depression. Annual Meeting of the American Psychiatric Association, 2006, Toronto, Canada, research poster board NR250. (3) All atypical prescriptions: Total prescriptions Jan 06 to Mar 06. IMS Health. National Prescription Audit. (4) Frank, Ellen. Major Depression. NAMI. May 2003. Available at: http://www.nami.org/Template.cfm?Section=By_Illness&Template=/T aggedPage/TaggedPageDisplay.cfm&TPLID=54&ContentID=23039&lstid= 326. Accessed on May 1, 2006. (5) Lundbeck Institute. Psychiatric Rating Scales. PDF available at: http://www.brainexplorer.org/factsheets/Psychiatry%20Rating%20S cales.pdf. Accessed on May 1, 2006.
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