FDA Approves Risperdal Consta

Risperdal Consta Approved for Schizophrenia

TITUSVILLE, N.J., October 30, 2003 -- The FDA has approved Risperdal Consta (risperidone) Long-acting Injection for the treatment of schizophrenia. This is the first long-acting, newer-generation (atypical) antipsychotic to gain such approval. The treatment uses advanced technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks.

This addresses a major challenge in the treatment of schizophrenia and helps patients, clinicians and families/caregivers know with certainty that patients receive needed medication for this serious brain disorder. As many as 75 percent of patients with schizophrenia have difficulty taking their oral medication on a regular basis. This may lead to worsening of symptoms.

Johnson & Johnson Pharmaceutical Research & Development and Alkermes Inc. developed Risperdal Consta. The product will be marketed by J&J subsidiary Janssen Pharmaceutica Products.

"By providing consistent levels of medication during a two-week period, Risperdal Consta eliminates many of the peaks and valleys that you get with medication that you have to take daily. Patients also don't have to remember to take a pill every single day, which is difficult for anyone with a chronic disease," said John Kane, M.D., executive director of The Zucker Hillside Hospital and professor of psychiatry at the Albert Einstein College of Medicine in New York. "It gives patients a new choice and helps them change their lives."

Clinical trial findings

The effectiveness of Risperdal Consta was established in a 12-week, placebo-controlled study in 400 adults with schizophrenia, both in inpatient and outpatient settings. Efficacy was assessed using the Positive and Negative Syndrome Scale (PANSS), a common measure of the total severity of 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 and loss of normal enjoyment).

Patients who received Risperdal Consta experienced significantly greater improvements in both positive and negative symptoms than did those who were administered placebo. Forty-seven percent of patients treated with a 25-mg dosage of Risperdal Consta experienced clinical improvement compared to 17 percent of those who received placebo. Clinical improvement is defined as 20 percent or more reduction in PANSS total score.

"Symptoms of schizophrenia such as hallucinations, paranoid thoughts and social withdrawal greatly interfere with a person's ability to live a normal life," said Dr. Kane. "Treatment options such as Risperdal Consta that reduce symptoms and help to ensure the continuity of therapy offer hope to patients and family members who have the same dreams for the future as everyone else."

Delivery technology

Risperdal Consta uses the proprietary Medisorb drug-delivery technology developed by Alkermes, Inc. The technology encapsulates active medication into polymer-based microspheres that are injected into the body, where they degrade slowly -- gradually releasing the drug at a carefully controlled rate.

To date, Risperdal Consta has been approved in more than 40 countries.

For more information in the near future, visit www.Risperdalconsta.com.

Source: Janssen Pharmaceutica Products www.janssen.com

Posted: October 2003

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