Source: Chest  |  Posted 10 years ago

TITUSVILLE, NJ -- March 14, 2002 -- The U.S. Food and Drug Administration today approved Risperdal? (risperidone) -- currently the No. 1 prescribed antipsychotic -- for delaying relapse in the long-term treatment of schizophrenia.

The expansion in the prescribing information for Risperdal is based on the results of a multicenter, randomized, double-blind study*, published last month in the New England Journal of Medicine. The study followed more than 300 stable outpatients with schizophrenia or schizoaffective disorder for at least a year, and for as long as 24 months. It found that Risperdal reduced the risk of relapse by 48 percent compared to haloperidol, a conventional antipsychotic long considered the "gold standard" for treatment of psychosis and which continues to be widely used throughout the world. Risperdal is the first newer "atypical" antipsychotic to significantly decrease the risk of relapse when compared to another antipsychotic.

More than two 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. Signs of the disease include so-called "positive" symptoms (such as delusions, hallucinations, disorganized thinking and paranoia) and "negative" symptoms (lack of drive or initiative, social withdrawal, apathy and emotional unresponsiveness).

According to the American Psychiatric Association, between 20 and 50 percent of people treated with medication are re-hospitalized every year due to the relapse of symptoms.

Made by Janssen Pharmaceutica Products, LP, Risperdal was first introduced in the United States in 1994 and is indicated for the treatment of schizophrenia.

Risperdal is currently available in 0.25, 0.5, 1,2,3 and 4 mg tablets as well as a 1mg/mL oral solution. In clinical trials, Risperdal was generally well tolerated. However, as with all other antipsychotic medications, Risperdal can cause some side effects. In two controlled trials involving individuals with schizophrenia and schizoaffective disorder, adverse events that occurred in at least 5 percent of patients receiving Risperdal and were experienced at least twice as often as those taking placebo were anxiety, drowsiness, extrapyramidal symptoms, dizziness, constipation, nausea, dyspepsia (upset stomach), rhinitis (runny nose), rash and tachycardia (rapid heart beat). While dose dependent, extrapyramidal symptoms typically occur at a rate that is comparable to that seen with placebo at doses less than or equal to 6 mg/day.

* This study was supported financially by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

SOURCE: Janssen Pharmaceutica Products, LP