Study Reveals Switch to Risperdal Consta(TM) Reduces Schizophrenia Symptoms Even in Stable Patients

Even schizophrenia patients already stabilized on older, long-acting injectable medications (commonly called depots) benefit significantly when switched to RISPERDAL CONSTA(TM) (risperidone), the first and only long-acting injection formulation of a newer-generation 'atypical' antipsychotic medicine, according to a new analysis of data from a one-year study presented today at a major U.S. psychiatry meeting*.

"Some clinicians are wary of switching patients who have been stabilised on older forms of long-acting injectables to newer alternatives but this research shows that treatment with Risperdal Consta can produce sustained improvement in symptoms, along with reduced adverse events, even in individuals whose illness is stable," said lead investigator Robert Conley, MD, assistant professor of psychiatry at the University of Maryland, USA. "This news offers renewed hope to patients and their families that further 'recovery' is possible. It also suggests that the benefits of Risperdal Consta may not be limited to simply improving treatment compliance, since patients already receiving continuous delivery of medication from a conventional depot continued to improve after switching to Risperdal Consta."

In the 12-month, open-label, Phase III study, conducted at 116 centres across 16 countries, 725 symptomatically stable patients with schizophrenia (615) or schizoaffective disorder (110) received injections of Risperdal Consta every two weeks. Overall, patients receiving Risperdal Consta achieved significant improvement in their total score on the PANSS (Positive and Negative Syndrome Scale). PANSS measures the severity of both "negative" symptoms (such as social withdrawal and apathy) and "positive" symptoms (including hallucinations and delusions).

A subgroup of 188 patients had previously received treatment with long-acting injectable forms of older, typical antipsychotics. After switching to oral Risperdal and then to Risperdal Consta, their average PANSS score improved significantly throughout the course of the study and at the 12-month conclusion. Half experienced a reduction in their PANSS score of greater than or equal to 20% and more than 15 percent reduced their PANSS score by 60 percent or more.

In this study, significant improvements in the severity of extrapyramidal symptoms (EPS) were seen in patients switched to Risperdal Consta. EPS (movement disorders that include stiffness, shaking and uncontrollable muscle spasms) are frequently side effects of older injectable antipsychotic medicines. Other adverse events experienced by patients taking Risperdal during the trial were mainly mild to moderate, with the most common being anxiety, psychosis, headache and insomnia. However, since Risperdal was not compared to placebo in this study, it is impossible to say which of these symptoms were actually caused by the medication.

The study was conducted by Johnson & Johnson Pharmaceutical Research & Development (J&JPRD). Risperdal Consta is marketed in most countries by Janssen-Cilag and has been approved to date in Germany, the United Kingdom, the Netherlands, Austria, Switzerland, Mexico and New Zealand. It is under regulatory review in a number of other countries around the world. Risperdal Consta was developed by J&JPRD 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 every two weeks.

The Janssen-Cilag companies are affiliates of Johnson & Johnson, the world's most diversified healthcare corporation. The companies 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 Eprex(R) (epoetin alfa), Risperdal(R) (risperidone), Sporanox(R) (itraconazole), Durogesic(R) (transdermal fentanyl), Topamax(R) (topiramate), Pariet(R) (rabeprazole sodium) and Reminyl(R) (galantamine). More information can be found at www.psychiatry24x7.com or www.janssen-cilag.com

* The organisation does not permit the use of its name in press releases.

SOURCE: Janssen-Cilag

CONTACT: Pam Rasmussen of Janssen-Pharmaceutica,

+1 609-730-2986 (U.S), or

[email protected]

Web site: http://www.janssen-cilag.com

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--Distributed by AsiaNet (www.asianetnews.net)--

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