Seroquel XR approved for treatment of bipolar disorder

Seroquel XR approved in Ireland for new indications for the treatment of bipolar disorder.

AstraZeneca wish to announce that the once-daily formulation Seroquel XR (quetiapine) has been approved for new indications in bipolar disorder. Seroquel XR has been approved for treatment of major depressive episodes in bipolar disorder and for the treatment of moderate to severe manic episodes in bipolar disorder. Until now there was no licensed treatment for bipolar depression in Ireland, making this approval a significant step forward for clinicians and patients.
The two new indications were supported by results from two randomised, double-blind trials which showed that Seroquel XR significantly reduced depressive and manic symptoms with improvements maintained for the duration of the studies.
Depressive and manic symptoms reduced as early as the first week of treatment with Seroquel
• Approval for the bipolar depression indication was based on an 8-week study conducted in in 277 patients, which found that Seroquel XR (starting dose 50mg daily; titrated up to 300mg daily from Day 4)significantly improved scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared with placebo at week 1 through week 8 (both p<0.001).(1)
• Approval for the bipolar mania indication was supported by a 3-week trial conducted in 311 patients, which demonstrated significant improvements with Seroquel XR (starting dose 300mg daily; range 400-800mg daily) in Young Mania Rating Scale (YMRS) scores at day 4 through study end compared with placebo (both p<0.001).(2 )
Well tolerated
Treatment with Seroquel XR was shown to be generally well tolerated in both studies and adverse events were consistent with the known safety profile of quetiapine (1,2). The most common adverse events associated with Seroquel XR in both studies were dry mouth, somnolence and sedation.
Conclusion
Commenting on the new indications for Seroquel XR, Professor Patricia Casey, Professor of Psychiatry at Department of Psychiatry, UCD and the Mater Misericordiae Hospital said: “We often forget just how debilitating the depressive episodes of bipolar disorder can be. Indeed their duration appears to last three times that of manic episodes. The availability of a product licensed to treat this pole of the disorder is welcome as it provides clinicians with a further tool in our therapeutic armamentarium”.
As a result of these new indications for adult patients, quetiapine is now the only antipsychotic agent indicated for the treatment of both poles of bipolar disorder in addition to its existing indication for schizophrenia.
1- Suppes T., et al. Effectiveness of the extended-release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression. Poster presented at the Collegium Internationale Neuro-psychopharmacologicum (CINP), Munich, Germany, 13-17 July, 2008.
2- Cutler A., et al. Effectiveness of extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar mania. Poster presented at the Collegium Internationale Neuro-psychopharmacologicum (CINP), Munich, Germany, 13-17 July, 2008.
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