UK drugmaker AstraZeneca says that new data have demonstrated the efficacy of its antipsychotic Seroquel (quetiapine fumarate) for the treatment of patients with major depressive episodes associated with bipolar disorder. Consequently, the company is planning to file for a US licence extension for the agent in the treatment of depressive episodes associated with bipolar disorder around the end of this year.

Results from the BOLDER II (BipOLar DEpRession) trial reinforce findings of the landmark BOLDER I study which first indicated a significant effect for the agent in treating bipolar depression, the group said. In addition, the trial has provided further evidence for the drug’s safety profile, showing it to be well tolerated with a low rate of serious adverse events.

Explaining the significance of the study’s findings, Professor Joseph Calabrese, co-director of the National Institute of Mental Health Bipolar Research Center at University Hospitals of Cleveland and Case Western Reserve University, said: “Patients with bipolar depression are underserved and understudied. The findings from the BOLDER II study are very encouraging and support the findings of BOLDER I, in showing the potential of Seroquel, as monotherapy, for the acute treatment for bipolar depression…The beneficial risk-benefit profile of Seroquel seen in both studies could offer an important therapeutic value for both patients and physicians as we currently have only one US Food and Drug Administration-approved therapy to treat depressive episodes associated with bipolar disorder.”

Approval for the treatment of bipolar disorder could substantially boost Seroquel’s sales, as the condition affects approximately 3-4% of the adult population and is the sixth leading cause of disability in the world, the company noted. The drug has been licensed for the treatment of schizophrenia since 1997, and is also cleared for the treatment of mania associated with bipolar disorder, and generated sales of $633 million for 2004 [[28/04/05a]].