April 24, 2005

Risperdal for Bipolar Disorder 1

From a Marketing Release from Janssen Pharmaceuticals:

RISPERDAL® (risperidone) has now been approved as monotherapy in Canada for the acute management of manic episodes associated with bipolar I disorder.

People with bipolar disorder may experience extreme changes of mood, swinging from deep depression to acute mania – excessive excitement, hyperactivity and sometimes, delusions and hallucinations. These manic episodes can lead to dangerous risk-taking behaviour. According to an American study, nearly 40 percent of people with untreated bipolar mania abuse alcohol and drugs.2 Job loss, divorce and even suicide are common consequences of the illness.2,3,4

"Manic symptoms can be difficult to treat," said Dr. Roger McIntyre, head of the Mood Disorders Psychopharmacology Unit, University Health Network. "The goal in treating mania is to provide safety and immediate control of symptoms. I've seen that successful management of mania reduces impairment and disruption in bipolar disorder. This new indication for RISPERDAL® means that patients have a new effective treatment option that provides rapid relief of these manic symptoms."

Clinical Trial Information

Evidence from three studies demonstrates that RISPERDAL®, taken alone, provides significant, rapid relief of manic symptoms associated with bipolar I disorder as early as three days after starting therapy. The treatment also was well tolerated by patients.5,6,7

In one double-blind study conducted over 12 weeks,6 438 patients experiencing a manic episode associated with bipolar I disorder were randomly assigned to take risperidone ( RISPERDAL® ), haloperidol or placebo for the initial three weeks. During the three-week period, both RISPERDAL® and haloperidol improved manic symptoms to a significantly greater degree than placebo, as measured by the Young Mania Rating Scale ( YMRS ). However, fewer of the patients taking RISPERDAL® experienced side effects such as extrapyramidal symptoms than those taking haloperidol.6 Extrapyramidal symptoms are a collection of symptoms that include trembling, decreased motor function or activity ( eg. muscle stiffness ) and body restlessness.8,9

During the studies, RISPERDAL® was well tolerated at the dose range of 1 mg to 6 mg per day. The majority of side effects were mild to moderate. Depending on the study, the most frequently reported side effects included somnolence ( sleepiness ), extrapyramidal symptoms and hyperkinesia ( a condition of excessive muscular activity ).5,6,7,10

RISPERDAL® is approved in more than 100 countries for a variety of conditions. In Canada, it also is approved for schizophrenia and for inappropriate behaviour caused by aggression and/or psychosis in severe dementia. RISPERDAL® is the most widely prescribed anti-psychotic in Canada.

About Bipolar Disorder

Bipolar disorder is a disease of the brain characterised by extreme shifts between depression ( episodes of severe sadness and/or hopelessness ) and mania ( episodes of extreme "highs" and energy ).11 Previously referred to as manic depression, bipolar disorder affects approximately one percent of the adult population in Canada.12

In Canada, untreated mood disorders have a major economic impact through related health care costs and lost work productivity12.

About Janssen-Ortho Inc.

Janssen-Ortho Inc. is a brand-name pharmaceutical company headquartered in Toronto with a broad range of medications used in psychiatry, neurology, dementia, attention deficit hyperactivity disorder, pain management, women's health, infectious disease, gastroenterology and urology.

1 RISPERDAL® and RISPERDAL® M-TAB™ Product Monograph, March 29, 2005. RISPERDAL® is indicated as monotheraphy for the acute management of manic episodes associated with Bipolar I disorder. The efficacy of RISPERDAL® in the treatment of acute Bipolar mania was established in three three-week placebo controlled trials. The safety and effectiveness of RISPERDAL® for long-term use, and for prophylactic use in Bipolar disorder has not been evaluated. Physicians who elect to use RISPERDAL® for extended period should periodically re-evaluate the long term risks and benefits of the drug for the individual patient.

2 Hirschfeld RM, Lewis L, Vornik LA. Perceptions and impact of bipolar disorder: how far have we really come? Results of the national depressive and manic-depressive association 2000 survey of individuals with bipolar disorder. J Clin Psychiatry. 2003; 64:161-74.

3 Calabrese JR, et al. Impact of bipolar disorder on a U.S. community sample. J Clin Psychiatry. 2003; 64:425-32.

4 Goodwin FK, Jamison KR, editors. Manic Illness. New York: Oxford University Press; 1990.

5 Hirschfeld RM, Keck PE, Kramer M, et al. Rapid antimanic effect of risperidone monotherapy: a three-week multicenter, double blind, placebo-controlled trial. Am J Psychiatry. 2004;161:1057-1065.

6 Smulevich AB., Khanna S, Eerdekens M, Karcher K, Kramer M, Grossman F. Acute and continuation risperidone monotherapy in bipolar mania: a three-week placebo-controlled trial followed by a nine-week double-blind trial of risperidone and haloperidol. European Neuropsychopharmacology. 2005;15:75-84.

7 Khanna S, Vieta E, Lyons B, Grossman F, Kramer M. Risperidone monotherapy in acute bipolar mania. World Psychiatric Association International Thematic Conference. Diagnosis in psychiatry: integrating the sciences, Vienna, Austria, June 19-22, 2003. ( Accepted British Journal of Psychiatry 2005 ).

8 Risperidone ( systemic ). Drug Information for the Health Care Professional Vol 1., USPDI 22nd ed. MICROMEDEX Thomson Healthcare; 2002.

9 Stimmel GL. Schizophrenia. In: Herfindal ET et al, editors. Clinical Pharmacy and Therapeutics. 5th ed. Maryland: Williams & Wilkins; 1992. p. 944-956.

10 Stedman's Medical Dictionary. 24th ed. Maryland: Williams & Wilkins; 1982.

11 Goodwin FK, Jamison KR. Manic-depressive illness. New York: Oxford University Press; 1990.

12 Health Canada. A report on mental illness in Canada. October 2002.

More Information: Janssen-Ortho, Inc.

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