To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: APA: Aripiprazole Shows Promising Efficacy in Schizophrenia URL: http://www.pslgroup.com/dg/1D1EE6.htm Doctor's Guide May 16, 2000
PRINCETON, NJ and TOKYO, JAPAN -- May 16, 2000 -- According to new study results released, aripiprazole, a novel anti-psychotic in Phase III development was shown to be comparable to haloperidol in controlling the symptoms of schizophrenia. Aripiprazole was also shown to be better tolerated than haloperidol. The results of the study were presented during the annual meeting of the American Psychiatric Association. "We are very excited about the first Phase III study results with aripiprazole," says Peter S. Ringrose Ph.D., chief scientific officer, Bristol-Myers Squibb Company. "Our partner Otsuka has discovered a potentially best-in-class agent for the treatment of schizophrenia, and we hope that this drug could offer a highly effective and well-tolerated treatment option for the millions of people afflicted with this disorder, and possibly other forms of mental illness." "The study demonstrates that aripiprazole was very effective in reducing both the positive and negative symptoms of acutely psychotic patients and is better tolerated than haloperidol," says Hideyuki Miwa, director on board, research and development, Otsuka Pharmaceutical Co., Ltd. "We are encouraged by the results of this study and hope that once approved, the compound will be able to provide patients with an improved therapeutic alternative." The "Efficacy of Aripiprazole in Psychotic Disorders: Comparison with Haloperidol and Placebo," was a double-blind, multi-center, four-week comparison involving 414 hospitalized patients with a DSM-IV diagnosis of acute relapse of schizophrenia or schizoaffective disorder. Patients in the study were given either 15 mg of aripiprazole, 30 mg of aripiprazole, 10 mg of haloperidol, or placebo. The efficacy of both doses of aripiprazole and haloperidol were significantly superior to placebo on the total score on the Positive and Negative Syndrome Scale (PANSS) and the Brief Psychiatric Rating Scale (BPRS). Furthermore, the responders analysis (30 percent decrease from baseline in PANSS-total at last visit) indicated that both doses of aripiprazole were significantly better than placebo (p<0.05) while the response rate for haloperidol was not significantly different from placebo (p>0.1). Tolerability data from the study indicate that aripiprazole may produce meaningful advantages relative to haloperidol including fewer extrapyramidal symptoms and lack of hyperprolactinemia, a condition often produced by antipsychotic medications that can cause symptoms such as sexual dysfunction and loss of menstruation in women. In addition, aripiprazole appeared to be associated with limited weight gain and minimal sedation, concerns associated with some of the other currently used anti-psychotic therapies. Adverse events with aripiprazole were generally mild in nature and included nausea and dizziness. "No one medication, not even the newer, more effective medications, can successfully treat all of the persons with serious mental illness," said Laurie Flynn, executive director for the National Alliance for the Mentally Ill (NAMI). "Persons with severe disorders of the brain and their physicians need more treatment options." Schizophrenia is the most chronic and debilitating of all mental illnesses, affecting 2.2 million Americans and approximately one percent of the worldwide population. Schizophrenia interferes with a person's ability to think clearly, manage emotions, make decisions, and relate to others. The mental illness tends to manifest itself in early adulthood and is characterized by positive symptoms such as hallucinations, delusions, and paranoia, and negative symptoms such as social withdrawal and emotional flatness. It is a lifelong disorder with enormous medical, social, and economic consequences if left untreated. Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd., are collaborative partners in the development and commercialization of aripiprazole. A regulatory filing for schizophrenia in the U.S. is planned for late 2001. Otsuka is a diversified health care company guided by its philosophy: "Otsuka, people creating new products for better health worldwide." Its lines of business include ethical and OTC pharmaceuticals, diagnostic agents, clinical laboratory tests, and consumer nutraceutical foods and beverages. It develops and commercializes a number of therapeutic agents in circulatory, cardiovascular, gastrointestinal, respiratory, ophthalmologic, and dermatological areas. Otsuka is a leader in the clinical nutritional fluids, such as caloric solutions, with a 40 percent market share in Japan. It has business operations in 15 countries, including Japan, the U.S. and key Asian countries. Bristol-Myers Squibb Company is a $20 billion diversified, global health and personal care company whose mission is to extend and enhance human life. The company's neuroscience franchise encompasses a variety of established products, such as Serzone(R) (nefazodone HCl) for the treatment of depression and BuSpar(R) (buspirone HCl USP) for anxiety disorders. Its neuroscience pipeline includes a once-a-day formulation of Serzone and a maxi-K channel opener under investigation for stroke. Related Link: Bristol-Myers Squibb Company. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.