LEXINGTON, Mass. (AFX) - Biotech drugmaker Indevus Pharmaceuticals Inc. said Tuesday it will abandon its trial of pagoclone as a treatment for premature ejaculation, after a mid-stage clinical trial did not show significant improvement versus placebo.
Instead, the company has met with the Food and Drug Administration to plan a clinical trial using pagoclone to treat persistent developmental stuttering. The company plans to begin the late-stage clinical trial in the first half of 2007.
In a mid-stage clinical trial, pagoclone significantly reduced the frequency and duration of stuttering, and improved patients' evaluations of their instances of stuttering. However, in a nine-point doctor-rated evaluation, patients getting pagoclone saw a numerical but not a significant improvement over those taking placebo.
The FDA suggested the company test the drug in both adults and children, determine the minimum effective dose, and have the agency officially sign off on the clinical trial designs.
About 3 million people in the United States stutter, with males affected about four times more often than females.
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