Risperdal (Risperidone) Quick Dissolve Tablets Launched In US

Schizophrenia Update, October 2003

TITUSVILLE, NJ -- May 6, 2003 -- A new, fast-dissolving form of the schizophrenia medication Risperdal® (risperidone) is launching this week. Risperdal M-TAB(tm) dissolves in seconds when placed on the tongue. Risperdal, marketed by Janssen Pharmaceutica Products, L.P., is the most widely prescribed antipsychotic medication in the United States.

"Many individuals can't, won't or just would prefer not to swallow pills. Having an option like Risperdal M-Tab will be useful in helping to ensure patients are able to take their medication regularly," said Dilip Jeste, MD, professor of psychiatry and neurosciences and chief of the Division of Geriatric Psychiatry at the University of California, San Diego (UCSD).

Atypical antipsychotic medications are the most commonly prescribed treatments for schizophrenia -- a disease that affects 2 million Americans and includes symptoms such as agitation, depression, anxiety, delusions, social withdrawal and a diminished capacity for organized thought.

Delivery Technology
Risperdal M-Tab tablets are produced using freeze-drying technology, creating highly porous tablets that rapidly disintegrate upon contact with saliva. The coral-colored, peppermint-flavored tablets will be available in 0.5 mg, 1 mg and 2 mg doses and are bioequivalent to comparable dosages of the original-formulation tablets.

In clinical trials, Risperdal was generally well tolerated. However, as with all other psychotropic medications, Risperdal is associated with side effects. In two controlled trials involving individuals with schizophrenia or schizoaffective disorder, adverse events with an incidence of 5 percent or greater in at least one of the Risperdal groups and that occurred at a rate that was at least twice that of 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). For more information, refer to the full prescribing information for Risperdal or visit



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