| AstraZeneca Seeks Seroquel XR Approval Extension
AstraZeneca said on Wednesday it was seeking approval from U.S. regulators to sell an extended-release version of its Seroquel drug to treat both manic and depressive episodes associated with bipolar disorder. The Anglo-Swedish company said it based its submission to the U.S. Food and Drug Administration on clinical studies showing the once-daily pill effective in treating depression. Seroquel XR is currently approved in eight countries -- including the United States -- to treat schizophrenia in adults and represents a key product for the company struggling with a sparse pipeline of its own. In December, AstraZeneca said the extended release version of its blockbuster schizophrenia drug Seroquel had proved effective in treating depression, opening up a potential new market for the product.
Shareholders Sue Lilly Over Zyprexa Woes
Eli Lilly and Co. has paid more than $1 billion to settle legal battles over its top-selling drug Zyprexa, and it might have to write another large check soon. But a new lawsuit says the company should have known better. Two shareholders have accused Lilly executives and directors of recklessly disregarding risks posed by illegal drug marketing tactics, which have been alleged in lawsuits and newspaper articles. Lilly spokesman Phil Belt calls the lawsuit "groundless." But it is the latest in a string of challenges over Zyprexa, which has generated billions of dollars — and reams of litigation — for Lilly. Settling thousands of patient lawsuits over the drug, an anti-psychotic approved to treat schizophrenia, acute mania and bipolar disorder, has cost Lilly more than $1 billion.
UPDATE: Britney Spears wasn't on drugs, just crazy
While less well known than schizophrenia or bipolar disorder (manic-depressive illness), BPD is more common, affecting 2 percent of adults, mostly young women.1 There is a high rate of self-injury without suicide intent, as well as a significant rate of suicide attempts and completed suicide in severe cases.2,3 Patients often need extensive mental health services, and account for 20 percent of psychiatric hospitalizations.4 Yet, with help, many improve over time and are eventually able to lead productive lives. .
Organon's Asenapine Further Demonstrates Efficacy in Reducing Mania ...
VIENNA, Austria, Oct. 17 /PRNewswire/ -- New data show that asenapine -- a psychopharmacologic agent being developed by Organon -- is effective in treating acute manic episodes associated with bipolar I disorder. These results, from two Phase III clinical studies, were presented this week at the 20th European College of Neuropsychopharmacology (ECNP) Congress. "The results of these clinical trials add to the body of evidence supporting the clinical efficacy and safety of asenapine," said Roger S. McIntyre, M.D., Associate Professor of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada. "The complex nature of bipolar disorders suggests that we should have many treatment options available to physicians and patients.
Eli Lilly considers $1 billion fine to settle U.S. case
Internal Lilly marketing documents and e-mail messages showed that Lilly wanted to convince doctors to prescribe Zyprexa for patients with age-related dementia or relatively mild bipolar disorder. In one document, an unidentified Lilly marketing executive wrote that primary care doctors "do treat dementia" but leave schizophrenia and bipolar disorder to psychiatrists. As a result, "dementia should be first message" to primary-care doctors, according to the document, which appears to be part of a larger marketing presentation but is not marked more specifically. Later, the same document says that some primary care doctors "might prescribe outside of label." In late 2000, Lilly began a marketing campaign called Viva Zyprexa and told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.
Kerry Katona In Rehab After Knifepoint Robbery
Former Atomic Kitten singer and troubled star Kerry Katona has checked into rehab in a bid to combat severe depression. The British reality TV star and magazine columnist, 26, decided to enter London's The Priory clinic after she was robbed at knifepoint in her Cheshire, England home on Monday (16Jul07). Katona's publicist Max Clifford says, "Kerry has gone into the Priory. Bipolar disorder is something she has suffered from for some time, and the condition has, of course, been very much brought on by what happened. .
Astrazeneca Submits Supplemental New Drug Applications For Seroquel XR ...
AstraZeneca announced that the company has submitted two separate supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for once-daily SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder.
The bipolar mania submission is based on a clinical study of once-daily treatment with SEROQUEL XR, compared to placebo, with a primary endpoint of change in YMRS (Young Mania Rating Scale) total score (week 3), in 316 patients suffering from bipolar mania. The bipolar depression submission is supported by a clinical study of once-daily treatment with SEROQUEL XR, compared to placebo, with a primary endpoint of change from baseline in MADRS (Montgomery Asberg Depression Rating Scale) total score after 8 weeks of treatment, in 280 patients diagnosed with bipolar depression.
Mary Elizabeth (Molly) Shugrue, 26, Artist
Mary Elizabeth (Molly) Shugrue, age 26, died on Monday, Jan. 7 in Los Angeles, Calif., of cardiac arrest, following complications of schizophrenia and bipolar disorder. She was the daughter of Edward and Page Hurley Shugrue of Duxbury. Molly grew up on Boston's Beacon Hill, spent weekends at Duxbury's Island Creek Pond and summers in Chilmark. She attended Beacon Hill Nursery School and the Josiah Quincy Elementary School in Chinatown. After several years at Boston Latin School, she transferred to the Dublin School in Dublin, N.H., where she was class valedictorian. Molly was a member of Skidmore College's Class of 2004 until the onset of her illness, when she transferred to the School of the Museum of Fine Arts and pursued art studies. She then moved to Los Angeles, Calif., where she lived independently and continued her art.
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