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Shionogi Announces Commercial Availability of CUVPOSA™ (Glycopyrrolate) Oral Solution for Pediatric Chronic Severe Drooling Associated With Neurologic Conditions
Date:4/7/2011

s of study subjects. The FDA approval of CUVPOSA™ in July 2010 was based on the results of a 8-week randomized, double-blind, placebo-controlled Phase III study of 38 subjects which showed that 75% of children and adolescents treated with CUVPOSA™ experienced an improvement in symptoms, versus 11% who received placebo. CUVPOSA™ was also evaluated in a long-term, open-label, 24-week safety study in 137 patient subjects. Dry mouth, vomiting, constipation, flushing and nasal congestion were the most commonly reported adverse reactions.

About CUVPOSA™

CUVPOSA™ is an anticholinergic indicated to reduce chronic severe drooling in patients ages 3-16 with neurologic conditions associated with problem drooling (e.g., CP). CUVPOSA™ indirectly reduces the rate of salivation by preventing stimulation of acetylcholine receptors that are located on certain peripheral tissues such as salivary glands. CUVPOSA™ is dosed on a titration schedule based on weight, therapeutic response and adverse reactions. It must be administered to patients by caregivers using an accurate measuring device. Please see the full prescribing information at www.CUVPOSA.com for administration and dosing instructions.

Important Safety Information

CUVPOSA™ is contraindicated in conditions that preclude anticholinergic therapy (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis). CUVPOSA™ is contraindicated in patients taking solid oral dosage forms of potassium chloride. The passage of potassium chloride tablets through the GI tract may be arrested or delayed with coadministration of CUVPOSA™.

Constipation or intestinal pseudo-obstruction may occur when taking CUVPOSA™. Constipation is a common dose-limiting adverse reaction and ma
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SOURCE Shionogi Inc.
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