AstraZeneca Submits sNDAs for Seroquel XR™ for the Treatment of Bipolar Mania and Bipolar Depression
News Jan 03, 2008
AstraZeneca has 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 eight weeks of treatment, in 280 patients diagnosed with bipolar depression.
Doses of SEROQUEL XR administered in both the bipolar mania (400 mg to 800 mg/day) and bipolar depression (300 mg/day) studies were comparable to the FDA-approved recommended doses for SEROQUEL (quetiapine fumarate) immediate release tablets in those indications. Both studies met their primary endpoint and it is expected that they will be presented at major scientific congresses in 2008.
SEROQUEL XR is currently approved in eight countries including US, Canada and The Netherlands, for the acute and maintenance treatment of schizophrenia in adults.
Modified Form of Botox Could Replace Opioids as Treatment for Chronic PainNews
A modified form of botulinum toxin gives long-lasting pain relief in mice without adverse effects and, in time, could replace opioid drugs as a safe and effective way of treating chronic pain, according to new research.READ MORE
Key Ingredient in Diabetes Drug Modified to Improve Side EffectsNews
Improved medications for Type 2 diabetes are one step closer thanks to a new discovery reported this week. By modifying the key ingredient in current diabetes drugs, the researchers produced a compound that was effective for hyperglycemia in animal trials, yet without the most problematic side effects of current drugs.READ MORE
Tackling Cancer at Ground Zero: Designer Molecule Inhibits Protein TargetNews
A new molecule designed by University of Adelaide researchers shows great promise for future treatment of many cancers. The new molecule successfully targets a protein that plays a major role in the growth of most cancers.READ MORE
5th edition of the International Conference Clinical Oncology and Molecular Diagnostics
Jun 17 - Jun 18, 2019