Public Release: 

Risperdal® (risperidone) produces continuous improvement of 'manic' symptoms in bipolar disorder

Risperdal monotherapy better tolerated than 'gold standard'

Resolute Communications

21 September 2003 - Prague - When used alone, RISPERDAL® (risperidone) significantly improves symptoms of acute mania in persons with bipolar disorder as early as one week after treatment begins, according to data presented today for the first time at the 16th Congress of the European College of Neuropsychopharmacology (ECNP)1. Treatment with Risperdal also was associated with a lower incidence of extrapyramidal symptoms (movement disorders) than the older conventional antipsychotic haloperidol, which should make it easier for more patients to take their medication consistently.

Bipolar disorder is a serious psychiatric illness affecting approximately three percent of the worldwide population. People with bipolar disorder experience dramatic mood swings, from deep depression to acute mania (characterised by symptoms such as excessively "high" mood, racing thoughts, poor concentration and unrealistic beliefs about their own abilities and powers).

The double-blind study presented at the meeting was conducted over the course of 12 weeks. In the initial three-week period, 438 patients with bipolar mania were randomly assigned to take risperidone, haloperidol or placebo. After the three weeks, patients still on active therapy could continue on 'blinded' treatment (risperidone or haloperidol, without knowing which medication they were receiving) for a further nine weeks, while those receiving placebo were switched to risperidone. During the total 12-week study period, the mean modal doses were 4.1 mg/day for risperidone and 7.4 mg/day for haloperidol.

During the initial three-weeks, efficacy was measured using the Young Mania Rating Scale (YMRS). Significantly greater improvements were seen in those who took risperidone or haloperidol than in those who received placebo.

By the end of this period, treatment response was achieved by 48 percent of risperidone patients and 47 percent of the haloperidol group, compared with just 33 percent of people who received placebo.

Treatment response was defined as a reduction in the total YMRS score that was greater than or equal to 50 percent. Response was significant at the first, second and third weeks for treatment with risperidone, whereas for haloperidol, the difference from placebo was significant only at week two. During the 12-weeks of double-blind treatment further improvements were seen. While 50 percent of the original risperidone group completed 12 weeks of double-blind treatment, only 39 percent of the haloperidol group did so, with side effects the main reason for discontinuation.

One of the potential risks associated with treating bipolar patients with manic symptoms is the possibility of triggering depression. In this study, Risperdal treatment improved symptoms of depression in patients with bipolar disorder. In contrast, haloperidol improved depressive symptoms at some points in time, it did not do so at others. The research also showed that Risperdal was better tolerated than haloperidol, with a lower incidence of extrapyramidal symptoms (EPS). EPS frequently result from treatment with antipsychotic medication and include movement disorders or muscle disturbances such as restlessness, muscular spasms, tremors and muscle stiffness.

"These data, together with other study findings, indicate that risperidone can significantly and rapidly alleviate acute mania when given alone or in combination with mood stabilisers," said Professor Allan Young, honorary consultant with the Department of Psychiatry, University of Newcastle in the UK. "Perhaps the most important finding from this study is that regardless of the presence or absence of psychosis, risperidone was consistently effective in reducing the symptoms of mania."

Risperdal is the world's most widely prescribed, newer-generation ('atypical') antipsychotic. It is approved for a variety of conditions in more than 80 countries, including treatment of schizophrenia, behavioural and psychological disturbances in patients with dementia, acute mania associated with bipolar disorder and disruptive behaviour disorders.

The formulation of Risperdal can be selected to suit the unique needs of patients; it is available in tablet form (both standard and fast-dissolving), as an oral solution and as a long-acting injection called Risperdalâ Constaä, the first long-acting formulation of a modern antipsychotic. It is administered just once every two weeks, rather than daily.

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For further information, contact:
Pam Rasmussen
Johnson & Johnson
Global Pharmaceutical Communications
Worldwide
+1 609-730-2986 (U.S.)
prasmus@gpcus.jnj.com

Brigitte Byl
Johnson & Johnson
Global Pharmaceutical Communications
Europe, Middle-East, Africa
+32 (0)2-749-2772 (Belgium)
bbyl@gpcbe.jnj.com

Notes to editor:
The Janssen-Cilag companies, which are members of the Johnson & Johnson (NYSE:JNJ) family of companies, one of the world's most diversified healthcare corporations - have a long track record in developing and marketing treatments for central nervous system disorders, pain management, fungal infections and gastrointestinal conditions. Leading products include Concertaâ (ADHD), Durogesicâ (pain management), Eprexâ (anemia), Parietâ (gastroenterology), Topamaxâ (epilepsy), Reminylâ (Alzheimer's disease) and Risperdalâ (schizophrenia). More information can be found at www.psychiatry24x7.com or at www.janssen-cilag.com

References:
1. Kramer M, Karcher K, Grossman F. Risperidone monotherapy in acute bipolar mania. Presented at the 16th ECNP in Prague, 20-24 Sept 2003

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