AstraZeneca announced clinical trial data for SEROQUEL? sustained release formulation (quetiapine fumarate sustained release), at the European Congress of Psychiatry (ECP) in Madrid.
The data demonstrated that the SEROQUEL? sustained release formulation (quetiapine fumarate sustained release), administered once daily, significantly improved symptoms associated with schizophrenia (measured by PANSS) and increased the time to psychiatric relapse, when administered through a three-step dose initiation aimed at reaching the effective dose range on the second day of treatment.
SEROQUEL? sustained release formulation is currently under review by regulatory authorities around the world for the treatment of schizophrenia and has not been approved in any market.
A randomised, double-blind study of 588 patients with acute schizophrenia (Study 132) compared SEROQUEL? sustained release formulation (400 mg/day, 600 mg/day or 800 mg/day) with placebo and found a significant improvement in Positive and Negative Syndrome Scale (PANSS) total scores from baseline for all doses. After six weeks? treatment, reductions of 24.8 (p=0.03), 30.9 (p<0.001), and 31.3 (p<0.001) points were seen with 400, 600, and 800 mg doses, respectively, compared with a reduction of 18.8 points for placebo. Patients on SEROQUEL? sustained release formulation also had significantly better scores on the Clinical Global Impression (CGI)-Severity scale and significantly more patients showed improvement on the CGI-Improvement scale compared to placebo.A second randomised, double-blind placebo controlled study (Study 004) examined time to first psychiatric relapse in 197 patients with clinically stable schizophrenia treated with either SEROQUEL? sustained release formulation (mean dose 669 mg/day) or placebo. Patients treated with SEROQUEL? sustained release formulation experienced a significantly reduced risk of relapse (risk reduction of 87 percent, p<0.0001), and a significantly longer time to relapse, compared with those on placebo. Differences in relapse rate between active treatment and placebo were large enough to require the study to be stopped early, in accordance with the study protocol. In the SEROQUEL? sustained release group, the estimated risk of relapse after six months was 14.3 percent versus 68.2 percent in the placebo group (p<0.0001). Hospitalisation due to worsening of schizophrenia was required by 8.3 percent of patients on placebo, but was not needed for any patients taking SEROQUEL? sustained release formulation.Professor Rene Kahn, Professor and Chair of the Department of Psychiatry and Head of the Division of Neuroscience at the University Medical Center, Utrecht, said: ?In these studies SEROQUEL? sustained release formulation showed its potential as a once-daily treatment for both acute and clinically stable schizophrenia. Statistical significance on the primary endpoint was seen at doses between 400 and 800 mg/day and patients achieved that range within two days of starting treatment ? that is an advantage over original formulation quetiapine, where the initial dose escalation is not so simple. In mental healthcare, striving for treatment that is simpler and more practical is an important objective for patients and doctors.?In both studies, somnolence and dizziness were the most common adverse events with SEROQUEL? sustained release formulation and these were generally mild or moderate, transient, and did not lead to withdrawal from the trials. The incidence of extrapyramidal adverse events was similar to placebo (EPS-related adverse events were seen in 5.1 percent of patients taking placebo versus 2.7 percent [400mg], 8.0 percent [600mg] and 4.1 percent [800mg] of patients taking SEROQUEL? sustained release formulation in the acute study).