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Many Patients With Schizophrenia Who Transitioned to Risperdal Consta Avoided Relapse and Experienced Symptom Improvement

TITUSVILLE, NJ -- June 16, 2005 -- A study presented at the 45th Annual New Clinical Drug Evaluation Unit (NCDEU) meeting in Boca Raton, Florida, reports that many patients with schizophrenia or schizoaffective disorder who transitioned from other medications to Risperdal(R) Consta(R) (risperidone long-acting injection) avoided relapses and experienced symptom improvement. Janssen, L.P., which markets Risperdal(R) Consta(R), supported this study.

"Schizophrenia is debilitating and proper treatment can help patients regain control of their lives," said George M. Simpson, MD, chairman, Department of Psychiatry, Keck School of Medicine, University of Southern California. "This study showed that continuous therapy with risperidone long- acting injection helped many people with schizophrenia avoid relapse and manage their condition."

The primary endpoint of this study was to detect a statistical difference in time to relapse between the 25 and 50 mg doses of Risperdal(R) Consta(R). There was no statistical difference between the two doses of Risperdal(R) Consta(R) with respect to time to relapse. This finding suggests that it may be reasonable to initiate treatment for symptomatically stable patients with the lower dose. In this one-year study, relapse was noted in 22% of subjects receiving the 25 mg dose, and 15% receiving the 50 mg dose. Relapse was defined as the need for psychiatric hospitalization (noted in 10 percent and 6% in the 25 mg and 50 mg groups, respectively), substantial clinical deterioration (noted in 6% and 4% of subjects, respectively), increase in the level of psychiatric care (noted in 3 percent and 1% of subjects, respectively), violent behavior (noted in 1 percent and <1% of subjects, respectively), and qualified use of oral risperidone supplementation (noted in 3% and 3% of subjects, respectively).

The study also found that patients' psychotic symptoms decreased significantly versus baseline in both dose groups. Further, the number of patients considered "not ill," "borderline ill" or "mildly ill" improved from 43% at baseline to 61% in the 25 mg group, and from 48% at baseline to 63% in the 50 mg group.

This double-blind, randomized, controlled trial of Risperdal(R) Consta(R) in the treatment of chronic schizophrenia (n=323), followed patients who had been taking only oral antipsychotic medications and who were symptomatically stable for four months. Patients received a fixed dose of either 25mg or 50 mg of Risperdal(R) Consta(R) every two weeks. One hundred and sixty-six patients (51%) completed the 52-week study.

To determine how well the treatments worked, researchers measured whether patients relapsed and the length of time before they relapsed.

The most common side effects reported in the study include insomnia (28 percent), psychotic disorder not otherwise specified (20%), headache (19%) and anxiety (16%). Overall, weight remained essentially unchanged from baseline (196 pounds) to endpoint (198 pounds).

More than two million Americans suffer from schizophrenia, a devastating brain disorder characterized as the most chronic and disabling of the severe mental illnesses. People with schizophrenia often suffer symptoms such as hearing voices not heard by others, or having false beliefs that people are plotting against them or planning to harm them. These symptoms may leave them fearful and withdrawn.

Sponsored by the National Institute of Mental Health (NIMH), the NCDEU meeting is a scientific conference that brings together academic researchers from multiple disciplines involved in clinical trials, investigators with the pharmaceutical industry, and representatives from NIMH/National Institutes of Health and the Food and Drug Administration who are interested in psychopharmacology and the broader areas of interventions and services research.

Risperdal(R) Consta(R) (risperidone long-acting injection) is the first and only long-acting, atypical antipsychotic to be approved by the U.S. Food and Drug Administration and now is approved in more than 57 countries worldwide. The treatment uses advanced technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks. Risperdal(R) Consta(R) is manufactured by Alkermes, Inc., and marketed in the United States by Janssen, L.P. Available in 25 mg, 37.5 mg and 50 mg dose units, it is approved for the treatment of schizophrenia. For more information, visit http://www.risperdalconsta.com.

Important safety information: elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Risperdal(R) Consta(R) (risperidone long-acting injection) is not approved for the treatment of patients with Dementia-Related Psychosis.

In a study of people taking Risperdal(R) Consta(R), most common side effects were: sleepiness, restlessness, tremors and muscle stiffness, stomach upset, constipation, dry mouth, feeling tired, and weight increase.

Studies suggest an increased risk of elevated blood sugar-related side effects, which are sometimes potentially fatal, in patients treated with this class of medications, including Risperdal(R) Consta(R). Some people may need regular blood sugar testing.

Patients may have heard the term "tardive dyskinesia." These are potentially persistent, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type. If patients have these symptoms, they should talk with their health care professional.

A rare but serious side effect that has been reported with this kind of medicine, including Risperdal(R) Consta(R), is known as NMS or neuroleptic malignant syndrome. NMS is characterized by muscle rigidity, fever and can be serious.


SOURCE: Janssen, L.P.

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