LONDON, March 18 /CNW/ - AstraZeneca today announced SEROQUEL(R)
sustained release formulation (quetiapine fumarate sustained release) clinical
trial data presented at the European Congress of Psychiatry (ECP) in Madrid.
The data demonstrated that the SEROQUEL(R) sustained release formulation
(quetiapine fumarate sustained release), administered once daily,
significantly improved symptoms associated with schizophrenia(1) (measured by
PANSS) and increased the time to psychiatric relapse(2), when administered
through a 3-step dose initiation aimed at reaching the effective dose range on
the second day of treatment.
SEROQUEL(R) sustained release formulation is under review by regulatory
authorities around the world for the treatment of schizophrenia and has not
been approved in any market.
A randomized, double-blind study of 588 patients with acute schizophrenia
(Study 132) compared SEROQUEL(R) 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.(1) After 6 weeks of treatment, reductions of 24.8 (p=0.03), 30.9
(p(less than)0.001), and 31.3 (p(less than)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(R) 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 randomized, double-blind placebo controlled study (Study 004)
examined time to first psychiatric relapse in 197 patients with clinically
stable schizophrenia treated with either SEROQUEL(R) sustained release
formulation (mean dose 669 mg/day) or placebo(2). Patients treated with
SEROQUEL(R) sustained release formulation experienced a significantly reduced
risk of relapse (risk reduction of 87%, p(less than)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(R) sustained release group, the estimated risk of
relapse after 6 months was 14.3% versus 68.2% in the placebo group (p(less
Hospitalization due to worsening of schizophrenia was required by 8.3% of
patients on placebo, but was not needed for any patients taking SEROQUEL(R)
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(R) 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(R) 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% of patients taking placebo
versus 2.7% (400mg), 8.0% (600mg) and 4.1% (800mg) of patients taking
SEROQUEL(R) sustained release formulation in the acute study(1)).
Other new SEROQUEL(R) sustained release formulation studies presented at
the congress show that patients who are currently receiving original
formulation quetiapine, or who are inadequately treated with another
antipsychotic agent, could be easily switched to SEROQUEL(R) sustained release
formulation. Among clinically stable patients who switched from original
formulation quetiapine, there were no significant differences between SEROQUEL
sustained release formulation and the original formulation quetiapine in PANSS
total scores after 6 weeks treatment (mean PANSS total score at day 42 was
55.4 and 54.8 for the sustained release formulation and the original
formulation respectively) and the incidence of adverse events was similar
(Study 146). (3) Among patients who switched to SEROQUEL(R) sustained release
formulation from other antipsychotics, 62.8% achieved improved clinical
benefit (based on CGI-CB scores) regardless of the reason for switching
(insufficient efficacy or intolerability of initial treatment, Study 147) (4).
Based on these data and data from other trials, regulatory filings for
the treatment of schizophrenia with SEROQUEL(R) sustained release formulation
were submitted to the authorities in the US, EU and other markets in 2006.
Beyond schizophrenia, ongoing clinical studies of SEROQUEL(R) sustained
release formulation cover bipolar disorder, major depressive disorder and
generalized anxiety disorder. SEROQUEL(R) (original formulation quetiapine) is
the number 1 prescribed atypical antipsychotic in the United States and global
sales for SEROQUEL(R) reached US$3.4 billion in 2006. It is licensed in 85
countries for the treatment of schizophrenia, in 73 countries for the
treatment of mania associated with bipolar disorder, and in October 2006 it
was approved in the US by the FDA for the treatment of bipolar depression. It
is estimated that more than 19 million patients have used SEROQUEL(R)
worldwide since its launch in 1997.
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of the
world's leading pharmaceutical companies with healthcare sales of US$26.47
billion and leading positions in sales of gastrointestinal, cardiovascular,
neuroscience, respiratory, oncology and infection products. AstraZeneca is
listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4
1. Kahn R, et al. Efficacy and tolerability of once daily quetiapine
sustained release in patients with acute schizophrenia: a randomised,
double blind, 6 week, placebo-controlled study. Presented at the
European Congress of Psychiatry, Madrid, Spain, 17-21 March, 2007.
2. Peuskens J, et al. Randomised, placebo-controlled, relapse-prevention
study with once-daily quetiapine sustained release in patients with
schizophrenia. Presented at the European Congress of Psychiatry,
Madrid, Spain, 17-21 March, 2007.
3. Mvller H-J, et al. Continued efficacy and tolerability in clinically
stable patients switched from quetiapine immediate release (IR) to
quetiapine sustained release (SR). Presented at the European Congress
of Psychiatry, Madrid, Spain, 17-21 March, 2007.
4. Ganesan S, et al. Clinical benefit of switching patients with
schizophrenia to once-daily quetiapine sustained release. Presented
at the European Congress of Psychiatry, Madrid, Spain, 17-21 March,
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