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Title: Risperdal Consta (Risperidone) Provides Significant Schizophrenia Symptom Relief

"Risperdal Consta (Risperidone) Provides Significant Schizophrenia Symptom Relief"

TITUSVILLE, NJ -- June 2, 2003 -- People with schizophrenia who were treated with Risperdal Consta ™ -- a new, long-acting formulation in development of the most widely prescribed antipsychotic, risperidone -- experienced significant symptom relief, with relatively low levels of side effects, in a study published today in the American Journal of Psychiatry. Risperdal Consta is currently approved in more than 20 countries. In the United States, discussions are ongoing with the Food and Drug Administration, which issued a non-approvable letter based on questions related to certain aspects of the pre-clinical data. Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) recently filed a response to the letter to support approval. An estimated 2 million Americans suffer from schizophrenia, a brain disorder that impairs a person's ability to think clearly, relate to others, and distinguish between reality and imagination. "Most experts believe that newer-generation, 'atypical' antipsychotics are the most effective and safest option for treating the symptoms of schizophrenia. Unfortunately, however, it is often difficult for patients with this disorder to take their medication consistently, on a daily basis. And when treatment is discontinued, the risk of relapse increases almost five- fold," said John Kane, MD, professor of psychiatry, neurology and neuroscience at the Albert Einstein College of Medicine in New York. "With Risperdal Consta, we expect that patients will get the benefits of a modern-class medication, in a form that only needs to be administered every two weeks." In the 12-week, double-blind study, 400 patients with schizophrenia were randomized to receive injections of placebo or Risperdal Consta (25mg, 50mg or 75mg) once every two weeks. Significant improvement was seen at all doses studied in both 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). An average of 45 percent of patients, depending on the dosage administered, saw a 20 percent or greater degree of symptom improvement. All doses of Risperdal Consta were well tolerated. The number of patients who dropped out of the study due to side effects was similar between the three groups receiving long-acting risperidone and those who took placebo (12 percent of the placebo group compared to 11, 12 and 14 percent of patients receiving a 25mg, 50mg or 75mg dose of risperidone once every two weeks, respectively). The most common side effects reported were headache, upset stomach, restlessness, drowsiness, constipation, fatigue and dry mouth. Rates of extrapyramidal symptoms (EPS), a concern with all antipsychotic medications, were similar between the groups receiving placebo (13 percent) and 25mg of Risperdal Consta (10 percent), the expected starting dose. At higher doses, EPS (such as slowness of movement, muscle spasms, or restlessness) rates were slightly higher among patients receiving the higher doses of Risperdal Consta compared to the placebo group (24 percent at 50mg and 29 percent at 75mg). Weight gain, another side effect of some antipsychotics, was minimal among patients receiving Risperdal Consta -- ranging from 1.1 pound over the course of 12 weeks among those administered 25mg, to 2.6 pounds among the 50mg group and 4.2 pounds for patients taking 75mg. Patients enrolled in the study were given oral risperidone for one week at the start of the study. Oral treatment continued for another three weeks after the injections began to provide a smooth transition between the oral and injectable formulations. The primary measure of efficacy was the Positive and Negative Syndrome Scale (PANSS). This commonly used scale measures the combined severity of positive and negative symptoms. Patients in all treatment groups experienced significantly greater improvements in their total PANSS scores at the end of the study than those who received placebo. Patients receiving Risperdal Consta rated pain associated with injection as low following the first injection, and ratings continued to improve through the final injection. The new, long-acting injectable formulation uses technology developed by Alkermes, Inc., of Cambridge, Mass., that allows the medication risperidone to be gradually released into the body. Using the proprietary Medisorb™ technology, risperidone is encapsulated in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and injected into the muscle. Laboratory and clinical research has shown that the microspheres gradually degrade at a set rate, providing therapeutic levels of the drug in the bloodstream for an extended period. The polymer from which the microspheres are made breaks down into two naturally occurring compounds that are then eliminated by the body. SOURCE: Janssen Pharmaceutica Products, L.P.

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