Public Release: 

Four-year data show risk of relapse is halved in Risperdal patients compared to haloperidol

Largest and longest such study ever undertaken

Resolute Communications

21 September 2003 - Prague - Treatment with RISPERDAL(risperidone), a newer- generation, 'atypical' antipsychotic medication, significantly reduces the risk of relapse in individuals experiencing their first episode of schizophrenia, even when using the lowest possible dose. Findings from the "FutuRis" study, the longest-term study in this population ever conducted, were presented today for the first time at the 16th Congress of the European College of Neuropsychopharmacology (ECNP)1,2,3.

"The results from this study are very encouraging, because schizophrenia is a life-long illness. This new research shows that if we can intervene effectively right at the start of the illness, upon the first psychotic episode, we may be able to prevent some of the consequences of this very debilitating disease,' said Professor Robin Emsley, MD, core investigator and head of the Department of Psychiatry at the University of Stellenbosch, South Africa. "We know that every time a person with schizophrenia relapses, it makes recovery slower and increases the frequency of future hospitalisation. The illness can also become more difficult to treat and -- in some cases -- resistant to treatment altogether. Therefore, it is essential that we minimise the number of relapses as much as possible early in the course of the disease."

The randomised, double-blind study followed 535 people with schizophrenia who took between 1-8 mg of risperidone or haloperidol per day for one to four years. It found that of the approximately three-quarters of patients who went into remission, 42 percent of those taking risperidone later relapsed, versus more than half (55 percent) for the older, conventional drug haloperidol. Haloperidol was chosen as the comparator because it is the most widely prescribed of the conventional antipsychotics. The study also showed that risperidone patients were relapse-free for more than twice as long as those receiving haloperidol (an average of more than 15 months, or 466 relapse-free days, for risperidone compared to seven months, or 205 days, for haloperidol).

Side effects of risperidone reported by study participants were low. Physicians and patients are typically most concerned about extrapyramidal symptoms (abnormal movements such as muscle twitching), which can be particularly prominent in persons with recent onset of the illness. When identical doses of risperidone and haloperidol were compared in this study, there were 20 to 38 percent fewer EPS cases reported for risperidone.

Schizophrenia is a debilitating illness that has no cure and affects about one in 100 people.4 This biological brain disorder seriously impairs a person's ability to think clearly, relate to others and function properly in society.

"Schizophrenia is a devastating experience for both the person experiencing the illness and their family and friends. Since one in 10 people with schizophrenia will resort to suicide, relapse prevention in persons with newly diagnosed schizophrenia has significant implications" said Professor Robin Emsley. "It is essential, therefore, that symptoms are identified and treated early and effectively."

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

In addition to traditional tablets, Risperdal is available in oral solution, fast-dissolving tablets and as a long-acting injection, Risperdalâ Constaä, the first and only such formulation for a modern antipsychotic.

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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:

Methodology
This randomised, double-blind trial involved 49 investigators from 11 countries and compared the effects of treatment with risperidone and haloperidol on the long-term outcome of early psychotic patients. A total of 535 patients received study medication for at least one year and were followed for a minimum of two and a maximum of four years. In the research, 266 patients (mean age 25.2) were treated with an average of 1.4mg/day of risperidone and 267 patients (mean age 25.7) were treated with an average of 1.4mg/day of haloperidol.

Relapse was defined as one of the following:

  • 25% increase in PANSS
  • CGI-C score of "much worse" or very much worse"
  • Deliberate self injury
  • Emergence of clinically significant suicidal or homicidal thoughts
  • Violent behaviour resulting in significant injury to another person or significant property damage.

Excluded from the analysis were 24.5% of risperidone and 22.2% of haloperidol patients whose symptoms did not remit.

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. Kopala, Rabinowitz, Davidson et al. Extra-pyramidal signs and symptoms (EPS) in recent onset schizophrenia: A comparison of risperidone and haloperidol. Presented at the 16th ECNP congress in Prague, 20-24 Sept 2003
2. Schooler, Davidson, Kopala et al. Reduced relapse rates in recent onset schizophrenia patients treated with risperidone vs, haloperidol. Presented at the 16th ECNP congress in Prague, 20-24 Sept 2003
3. Emsley, Davidson, Rabinowitz et al. Risk of akathisia in patients with recent onset schizophrenia treated with risperidone and haloperidol and its association with suicidality. Presented at the 16th ECNP congress in Prague, 20-24 Sept 2003
4. www.rethink.org, 4th September 2003

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