Green Signal To AstraZeneca Plc’s Schizophrenia Drug
The Food and Drug Administration on Friday gave green signal to AstraZeneca Plc’s schizophrenia drug. FDA approved an extended-release version of the bipolar-disorder drug Seroquel. This is the first the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder in US to be approved by FDA.
Patients suffering from psychological condition bipolar disorder have episodes of significant disturbance in mood. These patients are cycling between manic and depressive episodes. Risk of suicide is also high in patients suffering from Bipolar disorder.
According to Dr. Trisha Suppes, Professor of Psychiatry and Behavioral Sciences, Stanford University Medical Center and VA Palo Alto Health Care System said that in the long term, people suffering from bipolar disorder “experience depressive symptoms three times longer than manic symptoms."
Old version of this drug has to be taken twice-daily for bipolar mania moreover it is not approved for mixed episodes but Seroquel XR, the new version is a once-daily treatment for bipolar mania, biopolar depression and mixed biopolar episodes.
The approval to SEROQUEL XR was given after successful study involving 316 patients with bipolar mania or mixed episodes with or without psychotic features. A clinical study in 280 patients diagnosed with bipolar depression supported the bipolar depression submission.