New Phase III data on Organon's asenapine presented at the 20th Annual European Congress of Neuropsychopharmacology in Vienna.
Organon's asenapine further demonstrates efficacy in reducing
mania symptoms for the treatment of Bipolar I Disorder
New data from a separate study also show minimal effect on heart
rhythm changes in schizophrenia patients
VIENNA, Austria, October 17, 2007 – New data show that
asenapine – a psychopharmacologic agent being developed by
Organon – is effective in treating acute manic episodes
associated with bipolar I disorder. These results, from two Phase
III clinical studies, were presented this week at the 20th European
College of Neuropsychopharmacology (ECNP) Congress.
“The results of these clinical trials add to the body of
evidence supporting the clinical efficacy and safety of
asenapine,” said Roger S. McIntyre, M.D., Associate Professor
of Psychiatry and Pharmacology at the University of Toronto and
Head of the Mood Disorders Psychopharmacology Unit at the
University Health Network, Toronto, Canada. “The complex
nature of bipolar disorders suggests that we should have many
treatment options available to physicians and patients. As such, a
new therapy that provides efficacy while also providing improved
tolerability is critical in helping fill this unmet
need.”
In a separate safety study, also presented at the ECNP, asenapine
demonstrated minimal effect on the QT interval (QTc) – a
measure of the heart’s electrical conductance – in
patients with schizophrenia.
Study overview: bipolar I disorder (presented on Tuesday, 16
October at 12:00 p.m. CEST)
In the two Phase III, randomized, double-blind trials (Ares 7501004
and Ares 7501005), 960 adult patients with moderate-to-severe mania
associated with bipolar I disorder received either asenapine (5-10
mg twice daily), olanzapine (5-20 mg once daily), or placebo for
three weeks.
At day 21 in both studies, both asenapine and olanzapine produced
significant mean improvements in mania symptoms versus placebo as
measured by changes in YMRS (Young Mania Rating Scale) score. The
YMRS is an 11-item scale used to evaluate manic symptoms. A
difference in YMRS score reduction between the active treatments
and placebo was seen as early as day two1.
The overall incidences of treatment-related adverse events (AEs)
for the two studies were 55.1% and 60.8% in the asenapine groups,
46.8% and 52.9% in the olanzapine groups, and 27.6% and 36.2% in
the placebo groups. Most adverse events were mild to moderate. The
most commonly reported AEs (reported by >5% of the patients and
at twice the incidence of placebo in both studies) with asenapine
included sedation, dizziness and somnolence. Olanzapine was most
commonly associated with sedation, dizziness, somnolence and weight
increase. The incidence of extrapyramidal symptoms reported as an
adverse event was 10.3% and 7.2% in the asenapine group, 6.8% and
7.9% in the olanzapine group, and 3.1% and 2.9% in the placebo
group.
Asenapine-treated patients had approximately a two-fold lower
incidence of clinically significant weight gain (?7%) versus
olanzapine-treated patients in Ares 7501004 (7% vs. 19%,
respectively) and in Ares 7501005 (6% vs.13%, respectively). The
study abstract, “Treatment of mania in bipolar I disorder: a
placebo and olanzapine-controlled trial of asenapine,”
(P.2.e.012) was presented at ECNP on Tuesday, 16 October by
Professor McIntyre.
Study overview: schizophrenia (presented on Sunday, 14 October at
12:00 p.m.CEST)
This 16-day, multicenter study examined the effects of asenapine on
the QT interval – a measure of the heart’s electrical
conductance. A QTc >500 milliseconds (msec) and an increase from
baseline of >60 msec are risk factors for a potentially
life-threatening form of ventricular tachycardia called torsades de
pointes.
In the study, 151 patients with schizophrenia or schizoaffective
disorder were randomized to asenapine (up to 20 mg twice daily),
quetiapine 375 mg twice daily, or placebo. Investigators measured
QTc using electrocardiograms (ECGs), which were administered
several times throughout the 16-day study after asenapine
administration.
Asenapine at doses up to 20 mg twice daily had a minimal, not
considered to be clinically relevant, effect on QTc. Asenapine had
an effect equal to or less than quetiapine on QTc in this
study.
The study abstract, “Effect of asenapine versus quetiapine
and placebo on QTc interval in patients with schizophrenia,”
(P.3.c.050) was presented at ECNP on Sunday, 14 October by Sheldon
H. Preskorn, M.D., Department of Psychiatry, University of Kansas
School of Medicine in Wichita.
About bipolar disorder
Bipolar disorder, commonly referred to as manic-depressive
disorder, is a chronic, episodic illness characterized by mania
(episodes of elevated moods, extreme irritability, and increased
energy), depression (overwhelming feelings of sadness, suicidal
thoughts), or a combination of both. It affects approximately one
to five percent of adults, including more than 10 million adults in
the United States and more than four million people in Europe2,3.
The condition can start early in childhood or later in life, the
average age of onset is between 15 and 25 years old4. Bipolar
disorder is the sixth leading cause of disability in the world2.
About half of the patients with bipolar disorder who recover in
response to treatment experience recurrence two years later5.
About schizophrenia
Schizophrenia is a chronic, disabling brain disorder characterized
by hallucinations, delusions, and disordered thinking. About 24
million people worldwide (or seven in every 1,000 adults in the
population) have schizophrenia6, including more than two million
people in the U.S.7 and more than four million people in Europe8.
People with schizophrenia may hear voices other people don’t
hear or may believe others are trying to harm them. As a result,
they may become socially withdrawn, fearful, and agitated7.
References
1. National Institute of Mental Health. Available online at:
www.nimh.nih.gov/publicat/bipolar.cfm
2. Depression and Bipolar Support Alliance (DBSA). Bipolar Disorder
Statistics, accessed on May 10, 2007.
http://www.dbsalliance.org/site/PageServer?pagename=about_statistics_bipolar
3. World Health Organization. WHO European Ministry Conference on
Mental Health.
Available online at: http://www.euro.who.int/document/MNH/emnhqa.pdf.
Accessed on October 2, 2007
4. National Alliance on Mental Health. Understanding Bipolar
Disorder and Recovery.
Available online at:
http://www.nami.org/Template.cfm?Section=bipolar_disorder&template=/ContentManagem
ent/ContentDisplay.cfm&ContentID=44951
5. Perlis RH, Ostacher MJ, Patel JK. Predictors of Recurrence in
Bipolar Disorder: Primary
Outcomes from the Systemic Treatment Enhancement Program for
Bipolar Disorder
(STEP-BD). Am J Psychiatry. 2006;163:210-224.
6. World Health Organization. Available online at:
http://www.who.int/mental_health/management/schizophrenia/en/.
Accessed on October
2, 2007.
7. National Institute of Mental Health. Available online at:
http://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml
8. World Health Organization. WHO European Ministry Conference on
Mental Health.
Available online at: http://www.euro.who.int/document/MNH/emnhqa.pdf.
Accessed on
October 2, 2007.
About Organon
Organon creates, manufactures and markets innovative prescription
medicines that improve the health and quality of human life.
Through a combination of innovation and business partnerships,
Organon seeks to leverage its position as a leading
biopharmaceutical company
in each of its core therapeutic fields: fertility, gynecology and
selected areas of anesthesia. It has extensive expertise in
neuroscience and a rich and focused R&D program. Research areas
also include immunology and specific areas of oncology. Organon
products are distributed in over 100 countries worldwide, of which
more than 50 have an Organon subsidiary. Organon is the human
healthcare business unit of Akzo Nobel.
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issues as growth strategy, future financial results, market
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For the US only
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Director media relations Senior director communications & media relations
N.V. Organon Organon USA Inc.
Tel: +31 (0)412-665440 Tel: (973) 325-5353
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Posted: October 2007
