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™ (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
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