The U.S. Food and

Drug Administration has approved Cuvposa (glycopyrrolate), the first liquid treatment for patients ages 3-16 who suffer from chronic severe drooling associated with neurologic conditions such as cerebral palsy.

 

Cuvposa is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands. Cuvposa indirectly reduces the rate of salivation by preventing stimulation of these receptors. Cuvposa is available as a 1mg/5ml clear, cherry flavored oral solution.

 

This approval is based on the results of a randomized, double-blind, placebo-controlled Phase III study which showed that 75% of children and adolescents treated with Cuvposa experienced an improvement in symptoms, versus 11% who received placebo. Dry mouth, vomiting, constipation, flushing and nasal congestion were the most commonly reported adverse reactions.

 

Important Safety Information for Cuvposa

 

Contraindications

• Medical conditions that preclude anticholinergic therapy.
• Concomitant use of solid oral dosage forms of potassium chloride.
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Warnings and Precautions

• Constipation or intestinal pseudo-obstruction: May present as abdominal distention, pain, nausea, or vomiting. Assess patients for constipation, particularly within 4-5 days of initial dosing or after a dose increase.
• Incomplete mechanical intestinal obstruction: May present as diarrhea. If obstruction is suspected, discontinue Cuvposa and evaluate.
• High ambient temperature: To reduce risk of heat prostration, avoid high temperatures.