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Risperdal Consta (Risperidone), Newer-Generation Schizophrenia Treatment, Now Available in US

First New Approach to Schizophrenia Treatment in 14 Years

TITUSVILLE, NJ -- December 4, 2003 -- For the first time, physicians and patients with schizophrenia can choose a treatment option that combines the benefits of a newer-generation (atypical) antipsychotic medication with the convenience of an every two-week injection. Risperdal® Consta® [(risperidone) long-acting injection], the first and only long-acting atypical antipsychotic approved by the U.S. Food and Drug Administration for the treatment of schizophrenia, is now available. Risperdal Consta is the first new approach to treating schizophrenia since the arrival of the first atypical antipsychotic in the late 1980s.

Schizophrenia is a brain disorder that impairs a person's ability to think clearly, relate to others and distinguish between reality and imagination. It is estimated that more than 2 million Americans suffer from the condition. One of the biggest challenges in treating people with schizophrenia is ensuring that medication is taken routinely. In fact, as many as 75 percent of patients with schizophrenia have difficulty taking their oral medication on a regular basis.2

"Risperdal Consta offers physicians and patients a new way to approach and manage schizophrenia. Rather than worry about taking medication every day, or several times per day, patients can go to their doctors' offices once every two weeks to receive treatment," 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. "Patients with schizophrenia now have an option beyond daily oral medications. With Risperdal Consta, they can benefit from consistent medication levels. It gives patients a new choice and may help them change their lives."

Risperdal Consta uses the proprietary Medisorb® drug-delivery technology developed by Cambridge, Mass.-based Alkermes, Inc. This advanced technology encapsulates active medication into polymer-based microspheres, allowing the medication to be administered once every two weeks via injection. The microspheres degrade slowly in the body – gradually releasing the drug at a carefully controlled rate. Risperdal Consta is a prescription medication, and patients who are treated with Risperdal Consta must visit their health-care professional to receive the medication.

While individual results may vary, patients who were treated with Risperdal Consta in clinical trials report positive experiences. "I've done extremely well with this new medicine," said Paul R., who started treatment with Risperdal Consta almost a year and a half ago and continues to be treated with the medication. "I work out, go swimming, do errands and spend time with my wife. My goal is to be able to go back to work, which is something I think is achievable. A year ago, I don't know if I would have been able to say that."

Another patient, Charles H., also participated in a Risperdal Consta trial. He started treatment with the new long-acting injectable antipsychotic approximately six months ago and is continuing treatment. "With Risperdal Consta, my symptoms are under control. This medication really works for me. I now live on my own, something I wasn't able to do before because of my illness," he said.

Available in 25 mg, 37.5 mg and 50 mg dose units, Risperdal Consta is approved for the treatment of schizophrenia. Risperdal Consta will be covered under the federal Medicare program and under most state Medicaid programs.

To date, Risperdal Consta has been approved in more than 45 countries around the world. Risperdal Consta is manufactured by Alkermes, Inc. and marketed by Janssen Pharmaceutica Products, L.P. in the United States.

For more information about Risperdal Consta and schizophrenia, visit www.risperdalconsta.com. For more information about schizophrenia, visit www.mentalwellness.com.

In clinical trials, Risperdal Consta was generally well tolerated. The most common treatment-emergent adverse events with an incidence of 5 percent or greater in at least one of the Risperdal Consta groups (25 mg or 50 mg) and at least twice that of placebo were: somnolence, akathisia, parkinsonism, dyspepsia, constipation, dry mouth, fatigue and weight increase. As with all antipsychotic medications, prescribing should be consistent with the need to minimize the risk of tardive dyskinesia, a neurological side effect that can include repetitive twitching; if its signs and symptoms appear, discontinuation of Risperdal Consta should be considered. In the integrated database of multiple-dose studies, the incidence of tardive dyskinesia was 0.6 percent (9/1499 patients).

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) and Alkermes, Inc. developed Risperdal Consta to combine the advantages of long-acting delivery with the established benefits of oral risperidone.

Oral Risperdal has been marketed in tablet form in the United States by Janssen Pharmaceutica Products, L.P. since 1994 and is also available in oral solution and quick dissolving tablet forms. Approved for marketing in more than 100 countries, Risperdal is the most widely prescribed atypical antipsychotic in the world.


SOURCE: Janssen Pharmaceutica Products, L.P.

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