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A New Drug, Cuvposa, Approved for Treatment of Drooling
by admin on: April 22nd, 2011

As any parent knows, drooling in babies and infants is normal. In some circumstances, it may indicate that a baby is teething. Other times? Well, it may be hard to say. ???Normal??? development aside, excessive drooling may also result from neurological disorders. In these children, often between the ages of three and 16 years, there is a developmental disability whereby these children have a neuromuscular dysfunction that makes the act of swallowing difficult. Because of this difficulty, these children often drool.

Cuvposa (also known as Glycopyrrolate) is an oral solution that was approved on July, 2010 by the U.S. Food and Drug Administration (FDA) as a treatment to reduce chronic drooling in children aged three to 16 years who suffer from neurological conditions (such as cerebral palsy). The drug is classified an anticholinergic medication, and was previously approved by the FDA to treat peptic ulcers, and for reducing the amount of drooling patients under anesthesia exhibit.

The data from the clinical trials for Cuvposa indicated that 78 percent of the children administered this drug achieved pre-determined criteria for clinical improvement. This result compares favorably to the placebo-treated group which displayed a 19 percent of the sample population that achieved a state of clinical improvement. Prior to the approval of this formulation, Glycopyrrolate tablets were used to treat excessive drooling, and had to be crushed in order to be administered; of note, this type of use is referred to as an ???off-label??? use, meaning that the drug was not approved for use in this manner.

While the results from the clinical trials were positive, it should be noted that this drug should not be administered to patients who present with medical conditions that precluded pharmacological therapy with anticholinergic medications. In addition, Cuvposa should not be administered to patients who are currently treated with solid oral doses of potassium chloride.

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