New Two Week Psychosis Drug about to be introduced...
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New Drug Application for First Injectable, Long-Acting AtypicalAntipsychotic Submitted to FDA
TITUSVILLE, N.J., Sep 4, 2001 /PRNewswire via COMTEX/ -- A new drug application for a long-acting injectable formulation of Risperdal(R) (risperidone)* has been filed with the Food and Drug Administration by Janssen Pharmaceutica Products, LP, and similar filings are now being submitted with health authorities worldwide. If approved, it would be the first atypical antipsychotic medication available in a formulation suitable for long-term use that requires administration just once every two weeks, instead of daily doses.
Using proprietary Medisorb(R) technology developed by Alkermes, Inc., the new formulation encapsulates risperidone in "microspheres" made of a biodegradable polymer, which is injected into the muscle. Laboratory and clinical research has shown that the microspheres gradually degrade at a set rate designed to provide consistent levels of the drug in the bloodstream. The polymer from which the microspheres are made breaks down into two naturally occurring compounds that are then eliminated by the body. Alkermes is scheduled to manufacture this long-acting formulation of Risperdal pending regulatory approval.
Risperdal tablets, first introduced in the United States in 1994, have become the most widely prescribed atypical antipsychotic in the world, and the most commonly used antipsychotic of any type in the United States. It is indicated for the management of psychotic symptoms, such as those associated with schizophrenia -- a brain disorder that affects about 1-2 percent of the world's population (including 2 million Americans). Older, conventional antipsychotics have been available in longer-acting, injectable formulations, which have been associated with significant side effects.
In its current tablet and oral-solution formulations, Risperdal has been shown in clinical trials to be effective and generally well tolerated. However, as with all antipsychotic medications, it was associated with side effects. In two controlled trials, 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 (uncontrolled tremors and muscle stiffness), 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 per day taken orally.
* For more information on Risperdal, including the full prescribing information, health-care professionals and consumers may visit the Web site risperdal.com.
Janssen Pharmaceutica Products, L.P., is a wholly-owned subsidiary of Johnson & Johnson (NYSE: JNJ) with a long track record in developing and marketing treatments for central nervous system disorders. Based in Titusville, NJ, its other specialty areas include pain management, treatment of fungal infections and therapy for gastrointestinal conditions. More information on the company can be found at us.janssen.com.
Alkermes, Inc. (Nasdaq: ALKS) is a leader in the development of products based on sophisticated drug-delivery technologies. The company has several areas of focusing including (i) controlled, sustained-release of injectable drugs lasting several days to several weeks, using its ProLease(R) and Medisorb technologies and (ii) the development of pharmaceutical products based on proprietary pulmonary drug-delivery technologies using its AIR(TM) technology. Alkermes' first product, Nutropin Depot(TM), was launched in the United States by its partner, Genentech, Inc., in June 2000. Nutropin Depot is a long-acting form of Genentech's recombinant human growth hormone using Alkermes' ProLease technology. In addition to its Cambridge, Mass., headquarters, research and manufacturing facilities, Alkermes operates research and manufacturing facilities in Ohio and a medical affairs office in Cambridge, England. For more information about the company, visit alkermes.com.
SOURCE Janssen Pharmaceutica Products, L.P. |
