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news.Sciele Pharma has completed its Phase III safety trial utilizing a liquid formulation of glycopyrrolate to treat chronic, moderate-to-severe drooling in pediatric patients.
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This trial was designed to evaluate safety parameters for glycopyrrolate over a six-month period.
Larry Dillaha, chief medical officer of Sciele Pharma, said: “We are excited to have completed this phase III safety trial for glycopyrrolate. With the timely completion of this trial, our next step will be to file a new drug application with the FDA, which we expect to do in the third quarter of 2008.”