Symptom improvement seen in schizophrenia patients switched to Risperdal® Consta

September 22, 2003

21 September 2003 - Prague - People with schizophrenia and other psychiatric disorders can switch with ease from previous antipsychotic medications to RISPERDAL® CONSTA (risperidone long acting injection), the first and only newer-generation, long-acting injectable antipsychotic. In chronic schizophrenia patients previously stabilised on various antipsychotic medications, symptom relief continues to improve in individuals who switched to Risperdal Consta. These are the key findings of research presented today at the 16th Congress of the European College of Neuropsychopharmacology (ECNP)1. In addition, unlike previous studies, patients were switched to Risperdal Consta without a supplementary run-in period with oral risperidone.

An estimated one percent of the world's population suffers from schizophrenia, a brain disorder that impairs a person's ability to think clearly, relate to others, and distinguish between reality and imagination. The illness is marked by "positive" symptoms (psychological disturbances "added" as a result of the disorder, such as hallucinations, delusions, suspiciousness and paranoia) and "negative" symptoms (normal functioning the patient has "lost," resulting in lack of initiative, social withdrawal, lack of expression and emotional withdrawal).

The pan-European "StoRMi" (Switch to Risperidone Microspheres) study is currently ongoing, and the first results reported are from a subgroup of the German participants. This open-label, multi-centre study found that patients previously treated with other antipsychotic medication could be switched safely and effectively to Risperdal Consta without a three-week period of "overlap treatment" with oral risperidone. Patients were continued on their previous antipsychotic medication for the first three weeks after the Risperdal Consta injections started, but no transition period with oral risperidone was required. Both positive and negative symptoms, as well as symptom severity and treatment response, significantly improved over the course of six months - as measured by three different, validated scales*.

In the study, the reported side effects were mild to moderate in 85 percent of patients. Extrapyramidal symptoms (EPS) improved significantly by the first month of treatment and continued to alleviate throughout the study. EPS frequently result from antipsychotic medication and include movement disorders or muscle disturbances such as restlessness, muscular spasms, tremors and muscle stiffness.

"Risperdal Consta may provide the solution to many of the problems associated with older medications. These may range from non-compliance with treatment to low efficacy due to fluctuating medication levels in the blood,' said Professor Hans-Juergen Moeller, director of the Department of Psychiatry at the Ludwig-Maximilan University, Munich and lead investigator for StoRMi in Germany. 'The results from this study are therefore very encouraging."

Risperdal Consta is the first newer-generation, "atypical" antipsychotic available as a long-acting injection. It combines the increased efficacy and fewer side effects of an atypical antipsychotic with the benefits of a long-acting formulation. Risperdal Consta only needs to be given every two weeks, so patients do not have to worry about remembering to take their medication every day.

The StoRMi study was conducted by Janssen-Cilag. Risperdal Consta is marketed in most parts of the world by Janssen-Cilag, and has been approved to date in 35 countries. The drug was developed by Johnson & Johnson Pharmaceutical Research & Development using a novel technology originated by U.S.-based Alkermes, Inc., in which risperidone is encapsulated in tiny spheres of biodegradable polymer ("microspheres") that gradually degrade at a controlled rate following intramuscular injection.
-end-
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:
* As measured by the PANSS (Positive and Negative Syndrome Scale), mean PANSS total score decreased from 70 at baseline to 64 at endpoint. The Clinical Global Impression scale (measuring symptom severity and treatment response) improved significantly from baseline to endpoint (p=0.0001) and the Global Assessment of Functioning Scale (measuring overall severity of psychiatric disturbance) improved significantly from a mean of 59.5 to 65.8 (p=0.0001).

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. Moeller HJ, Schmaub M, Kissling W, Riedel M, Naber DH. Switch to Long-Acting Risperidone Microspheres - Results of a Prospective Trial. Presented at the 16th ECNP in Prague, 20-24 Sept 2003

Resolute Communications

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