Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced the U.S. commercial availability of CUVPOSA™ (glycopyrrolate) oral solution, the first and only FDA-approved treatment to reduce chronic severe drooling in patients aged 3 to 16 with neurologic conditions associated with problem drooling, such as cerebral palsy.
"Shionogi is proud to expand its mission of helping to bring high quality care to pediatric patients by introducing CUVPOSA™ to the U.S. market," said Donald C. Manning, MD, PhD, Chief Medical Officer of Shionogi Inc. "Unlike tablet formulations, liquid CUVPOSA™ does not require compounding by a pharmacist before it is administered by caregivers, providing families with a new approach to treating chronic severe drooling in children and adolescents with neurologic conditions."
Shionogi Inc. is partnering with Diplomat Specialty Pharmacy to grant caregivers convenient access to the newly-available treatment via a patient's physician. Once the physician places the order by calling 877.830.3797, Diplomat will verify the information, fill the prescription and ship to the patient. CUVPOSA™ is readily available as a clear, cherry flavored oral solution.
"Chronic severe drooling is an often overlooked condition affecting 10 to 30 percent of pediatric patients suffering from neurologic disorders," explained Dr. Robert Zeller, Director, Blue Bird Circle Clinic for Pediatric Neurology at Texas Children's Hospital and Professor, Baylor College of Medicine. "For these children and adolescents who exhibit excessive drooling, the availability of CUVPOSA™ offers an important advancement in therapy."
CUVPOSA™ has been classified by the FDA as an "Orphan Drug" that was developed to treat a rare disease or condition (chronic severe drooling). Clinical studies of orphan drugs do not typically contain high numbers 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.