AstraZeneca PLC, Europe's third-biggest drug maker, submitted a proposal to the U.S. Food and Drug Administration to market Seroquel as a treatment for bipolar disorder.
This would add a new use to its top-selling antipsychotic drug.
Bipolar disease is a mental illness that affects around 3 percent to 4 percent of the adult population and is the sixth leading cause of disability in the world.
Victims of the illness experience erratic mood swings - from feelings of euphoria and intense energy during episodes of mania to painfully melancholic lows during depressive episodes.
AstraZeneca reported that trials testing different doses of Seroquel found significantly reduced levels of bipolar disease compared to a placebo within the first week. Symptoms continued to be reduced throughout the eight-week study.
The drug giant submitted the proposal with some flair, describing it as an important milestone in the history of the drug. This may be warranted, because if the filing is successful, AstraZeneca will champion the only single agent intended to treat both the depressive and manic episodes associated with bipolar disorder.
Seroquel, which grossed more than $2 billion in sales last year, is already prescribed to treat acute manic episodes associated with bipolar disorder, as well as schizophrenia.
If approved, this new drug would condense into a single pill the ability to control the ups and downs that many bipolar patients endure.
This article is from MyDNA.com
© 2006 MyDNA.com