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SEROQUEL(R) Sustained Release Schizophrenia Data Presented at ECP Congress in Madrid

London (ots/PRNewswire)

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<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(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<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<0.0001). 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 Good Index.
References
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. Möller 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,
2007.
For further information, please visit www.astrazeneca.com or
www.astrazenecapressoffice.com.

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