"The research shows that switching these young adults to risperidone long acting injection improves further symptom control, reduces side effects and therefore helps them to stay on treatment, bringing them closer to remission, the ultimate goal," said Professor Hans-Juergen Möller, Director of the Department of Psychiatry at the Ludwig-Maximilan University, Munich and investigator for the StoRMi clinical study (Switch to Risperidone Microspheres) in Germany. "Data clearly has shown that early intervention in schizophrenia could help prevent progression of the disease and result in better long-term outcomes. It is therefore imperative to help patients control their symptoms as early as possible with the best possible medication."
An estimated one per cent 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).
As part of the StoRMi clinical study - an open-label, non-randomised, European multicenter study - a sub-group analysis was performed in 119 young adults from various countries with a mean age of 25 years (ranging from 18-30)*. The study was designed to investigate the benefits of switching patients considered stable on their previous antipsychotic treatment to risperidone long acting injection. More than half the patients were switched from oral atypical antipsychotics and 28 per cent from conventional depot antipsychotics. Patients were switched to risperidone long acting injection because of non-compliance (48 per cent), side effects (24 per cent) and insufficient efficacy (21 per cent) associated with their previous medications. The results showed that positive and negative symptoms of schizophrenia improved after one month and continued to improve during the six months of treatment with risperidone long acting injection – as measured by the PANSS (Positive and Negative Syndrome Scale).** PANSS measures the severity of both 'negative' symptoms and 'positive' symptoms. Approximately a third of the patients considered themselves to be either 'not ill' or 'borderline ill' at endpoint compared with 6 per cent at baseline.
In the study, patients on long acting risperidone experienced significant satisfaction with their treatment, 30 per cent rating it as 'very good' compared with 9 per cent at baseline with a trend towards an improvement in health-related quality of life during the trial. Extrapyramidal symptoms (EPS, movement disorders that include stiffness, shaking and uncontrollable muscle spasms) rated using the Extrapyramidal Symptom Rating Scale (ESRS) were found to significantly improve at one month and continued to decline throughout the six month treatment period.
Risperdal Consta is the first and only 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.
Risperdal Consta is marketed in most parts of the world by Janssen-Cilag, and has been approved to date in more than 50 countries for the treatment of schizophrenia. 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 embedded in tiny spheres of biodegradable polymer ("microspheres") that gradually degrade at a controlled rate following intramuscular injection.
For further information, contact:
Brigitte Byl
Johnson & Johnson
Global Pharmaceutical Communications
Europe, Middle-East, Africa
32-274-92772 (Belgium)
Bbyl@gpcbe.jnj.com
Notes to editor:
*Patients aged 18-30 years with schizophrenia or another psychotic disorder requiring long-term antipsychotic treatment therapy were eligible for inclusion in the study. All patients were required to be symptomatically stable on their previous antipsychotic regimen for > 1 month before enrolment in the trial
** As measured by the PANSS (Positive and Negative Syndrome Scale), 34% of patients had an improvement more than or equal to 20% of total PANSS score from baseline to treatment endpoint.
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 Concerta™ (ADHD), Durogesic™ (pain management), Eprex™ (anemia), Pariet™ (gastroenterology), Topamax™ (epilepsy), Reminyl™ (Alzheimer's disease), Risperdal™ (schizophrenia, acute bipolar mania, behavioural psychological symptoms of dementia, disruptive behaviour disorders) and Risperdal Consta (schizophrenia). More information can be found at www.psychiatry24x7.com or at www.janssen-cilag.com
The regulatory status of medicines and their potential indications as discussed in these materials may vary from country to country.
References:
1. P.T. Saleem, Horacio Firmino, Servico Psiquiatria, Eduard Parellada, Andreas Schreiner, Hans-Jürgen Möller. Young patients (18-30 years) with schizophrenia and schizoaffective disorder: results of direct switching to long-acting injectable risperidone (StoRMi trial). Presented at the twelfth winter workshop on schizophrenia, Davos, Switzerland, Feb 2004