Shionogi's CUVPOSA receives FDA approval for treatment of chronic severe drooling

Jul 30 2010

Shionogi Inc., a U.S.-based group company of Shionogi & Co., Ltd., today announced the U.S. Food and Drug Administration approval of 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™ 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™ 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.