Seroquel (Quetiapine) Sustained-Release Formulation Prevents Schizophrenia Relapse
Seroquel (Quetiapine) (original formulation) is considered to be a well-known prescribed atypical antipsychotic medicine in the United States. In October 2006 it was approved in the US by the FDA for the treatment of bipolar manic depression. By the way, another form, Quetiapine drug sustained release formulation for the treatment of schizophrenia disease, has not yet been approved and is under review by regulatory authorities around the world.
According to the updated information of AstraZeneca, the clinical trials showed that the once-daily generic Seroquel sustained-release formulation considerably improved symptoms associated with schizophrenia and lessened the time to psychiatric relapse. The results were demonstrated at the European Congress of Psychiatry (ECP) in Madrid.
There were conducted two randomized, double-blind placebo controlled studies involving 588 and 197 patients with acute schizophrenia. The aim was to compare Seroquel drug sustained release formulation with placebo. The first trial revealed a significant improvement in Positive and Negative Syndrome Scale (PANSS) after 6 weeks of treatment. Compared to placebo patients on Quetiapine medication sustained release formulation had better scores on the Clinical Global Impression (CGI)-Severity scale and it was obvious that more patients showed improvement on the CGI-Improvement scale. The second study inspected psychiatric relapse in patients with clinically stable schizophrenia. The findings were the following: patients taking generic Seroquel sustained release formulation had a significantly reduced risk of relapse, and a longer time to relapse, compared with those on placebo. Besides, the effectiveness of Seroquel 300 mg sustained release formulation as schizophrenia medication was so evident and large that the study was stopped early. After 6 months of investigation the appraised risk of relapse was 14.3% versus 68.2% in the placebo group.
Due to the two trials there were found out the most common adverse events with Quetiapine drug sustained release formulation: generally mild or moderate and transient somnolence and dizziness.
As Professor Mohan George of the Queen Elizabeth Psychiatric Hospital Birmingham considers, in mental healthcare, it is essentially important to supply doctors and patients with a choice of formulations. Regulatory filings for the treatment of bipolar schizophrenia with generic Seroquel sustained release formulation were submitted to the authorities in the US, EU and other markets in 2006. And except schizophrenia Quetiapine medicine sustained release formulation is inspected in bipolar disorder treatment and also in treating of generalized anxiety disorder and major depressive disorder.
