FLORHAM PARK, N.J., July 29 /PRNewswire/ -- Shionogi Inc., a U.S.-based group company of Shionogi & Co., Ltd., today announced the U.S. Food and Drug Administration approval of CUVPOSA(TM) (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(TM) was designated an Orphan Drug by the FDA.
"The FDA approval of CUVPOSA provides parents and caregivers the first liquid medication indicated to reduce chronic severe drooling," said Donald C. Manning, MD, PhD, Chief Medical Officer of Shionogi Inc. "Shionogi is proud to bring to market a product that treats an all-too-often unresolved yet damaging condition."
Cerebral palsy is a lifelong condition that encompasses a group of non-progressive, neurological disorders affecting body movement and muscle coordination. According to previous estimates from a study reported by the CDC, the national prevalence of CP is approximately 0.2% in children including 17 year olds. About 10-30 percent of children with CP suffer from excessive drooling, which can lead to various health issues such as skin irritation as well as a decreased quality of life.
CUVPOSA(TM) is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands. CUVPOSA(TM) indirectly reduces the rate of salivation by preventing stimulation of these receptors. CUVPOSA(TM) 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(TM) 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
-- Contraindications
-- Medical conditions that preclude anticholinergic therapy.
-- Concomitant use of solid oral dosage forms of potassium chloride.
-- 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(TM)
and evaluate.
-- High ambient temperature: To reduce risk of heat prostration,
avoid high temperatures.
-- Adverse Reactions
-- The most common adverse reactions are dry mouth, vomiting,
constipation, flushing, and nasal congestion.
-- To report SUSPECTED ADVERSE REACTIONS, contact Shionogi Drug
Safety Department at 1-800-849-9707 ext. 1454 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
-- Drug Interactions
-- Digoxin tablets: Use with glycopyrrolate can increase digoxin
serum levels. Monitor patients and consider use of alternative