Study Shows Organon's Asenapine Demonstrates Efficacy and Tolerability in Treating Acute Schizophrenia
OSS, Netherlands, November 14, 2007 /PRNewswire/ -- Asenapine -- a fast- dissolving, sublingual tablet being developed by Organon -- was shown to be effective and well-tolerated in patients with acute schizophrenia, according to a six-week study published in the current issue of the Journal of Clinical Psychiatry. These data were previously presented at the American Psychiatric Association's (APA) annual meeting and at the annual congress of the European College of Neuropsychopharmacology's (ECNP).
In the study, asenapine 5 mg twice daily was significantly more effective than placebo in improving both positive and negative symptoms associated with schizophrenia, based on the Positive and Negative Syndrome Scale (PANSS). This difference was seen starting at the second week of treatment. Positive symptoms include hallucinations and delusions; negative symptoms include lack of emotional expression.
"Currently available atypical antipsychotic drugs like risperidone are effective at reducing hallucinations and other positive symptoms associated with schizophrenia," said Steven G. Potkin, M.D., Department of Psychiatry and Human Behavior, University of California, Irvine. "Asenapine's effect on negative symptoms, as seen in our trial, is an interesting finding."
"These results further confirm asenapine's benefits in schizophrenia, and support our continued confidence in this agent as a potential treatment for this disorder," said Dr. Willem de Laat, executive vice president, medical affairs, Organon.
About the Study
In the study, 174 patients with schizophrenia were randomized to asenapine 5 mg twice daily, risperidone 3 mg twice daily, or placebo for six weeks. Asenapine was more effective than placebo in reducing total PANSS score as well as positive symptoms and negative symptoms when measured alone. Risperidone was more effective than placebo in reducing positive symptoms.
The majority of patients (83% asenapine, 79% placebo, 90% risperidone) experienced at least one adverse event (AEs) during the study. AEs were generally mild to moderate in severity. The most commonly reported AEs (greater than or equal to 10% of the patients) were: insomnia, somnolence, nausea, anxiety, and agitation in the asenapine group; insomnia, somnolence, anxiety, agitation, and headache in the risperidone group and agitation, headache, anxiety and dizziness in the placebo group. There was no difference between the treatment groups on the incidence of extrapyramidal symptoms. Prolactin levels (greater than or equal to 2 times the laboratory upper limit of normal) were higher in the risperidone group (79%) than in the asenapine or placebo groups (9% and 2%, respectively). Asenapine-treated patients reported a lower rate of clinically significant weight gain (greater than or equal to 7%) versus risperidone-treated patients (4.3% vs. 17%; 1.9% for placebo).
The study, Efficacy and Tolerability of Asenapine in Acute Schizophrenia: A Placebo- and Risperidone-Controlled Trial, is published in the Journal of Clinical Psychiatry (2007;68:1492-1500).
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 schizophrenia,(1) including more than two million people in the U.S.(2) and more than four million people in Europe.(3) 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 agitated.(2)
References (1) World Health Organization. Available online at: http://www.who.int/mental_health/management/schizophrenia/en/. Accessed on October 2, 2007. (2) National Institute of Mental Health. Available online at: http://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml (3) World Health Organization. WHO European Ministry Conference on Mental Health.
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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Posted: November 2007