Janssen Risperdal

Labeling change for risperidone including data on control of psychotic symptoms and aggressive behaviors associated with Alzheimer's will likely be approved by FDA in late January, the company says. The labeling change will incorporate clinical trials data and dosing information from a one-year open label extension of a 12-week, double-blind trial in which 330 Alzheimer's patients (average age 82.7) were treated with a mean dose of 0.96 mg/day of Risperdal. Of the 59 patients with pre-existing tardive dyskinesia symptoms, 50% showed persistent improvement. In patients without previous symptoms, 2.6% developed signs of TD