среда, 20 апреля 2011 г.

Overview Of Asenapine Data From Olympia Trial Program Presented At American Psychiatric Association Annual Meeting

Schering-Plough Corporation
(NYSE: SGP) announced that an overview of asenapine clinical trials
from the Olympia program was presented at the 161st Annual Meeting of the
American Psychiatric Association in Washington, D.C., May 3-8. Data from
the studies, involving patients with bipolar I disorder and schizophrenia,
were presented in two oral presentations (Abstracts # 44 and # 80). Also
presented were long-term safety and efficacy data from a clinical trial
involving patients with schizophrenia and schizoaffective disorders.



Asenapine, a fast-dissolving, novel psychopharmacologic agent with a
unique human receptor signature, was shown to be effective in two
short-term bipolar mania studies with a nine-week extension and in two out
of four short-term schizophrenia studies. In the third short-term
schizophrenia study, neither asenapine nor the active control
differentiated from placebo; in the fourth study, asenapine did not
differentiate from placebo, while the active control did. Overall,
asenapine was well tolerated in the Olympia trial program.



"Despite having effective treatments available, up to 75 percent of
schizophrenia patients(1) and many bipolar disorder patients stop taking
their medicines because of unwanted side effects or lack of efficacy," said
Roger 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. "Therefore, new
therapies that are both effective and well-tolerated would be welcome
additions to the treatment options currently available for improving
patient care."



Schering-Plough acquired asenapine in November 2007 through its
combination with Organon BioSciences, which developed the investigational
antipsychotic agent. The Food and Drug Administration is reviewing a new
drug application (NDA) for asenapine in the treatment for schizophrenia and
acute manic or mixed episodes associated with bipolar I disorder. The
asenapine Olympia clinical trial program thus far has involved over 3,000
patients and has included bipolar mania and acute schizophrenia trials.



"Based on results from the Olympia trial program, we believe asenapine
has the potential to address a clinically important unmet need for patients
with schizophrenia and bipolar disorder," said Robert J. Spiegel, M.D.,
Chief Medical Officer and Senior Vice President, Schering-Plough Research
Institute.



Olympia Data: Bipolar I Disorder



The bipolar I disorder program includes two placebo- and
active-controlled, three-week trials followed by an extension study
totaling one year of treatment involving nearly 1,000 patients with bipolar
I disorder. Treatment response was measured using the Young Mania Rating
Scale (YMRS) score, an 11-item scale used to evaluate manic symptoms.
















In the trials, both asenapine and the active-control drug olanzapine
produced greater mean reductions in YMRS total scores versus placebo after
three weeks of treatment. Asenapine produced 13- and 14-point reductions in
the YMRS total score from baseline to day 21 (P

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