Merz, Inc. (U.S. affiliate of Merz Pharma Group) today announced the acquisition of CUVPOSA® (glycopyrrolate) oral solution for pediatric chronic severe drooling associated with neurologic conditions such as cerebral palsy.
Cerebral palsy (CP) 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 (aged 3-16). About 10-30% of children with CP suffer from chronic severe drooling (sialorrhea), which can lead to various health issues such as skin irritation as well as a decreased quality of life.
"The FDA has classified CUVPOSA® as an orphan drug since sialorrhea is a rare disorder in pediatric patients with neurologic conditions," said Kapil D. Sethi, MD, FRCP, Professor of Neurology and Director of the Movement Disorders Program at Georgia Health Sciences University and Senior Medical Expert of Neurology at Merz Pharmaceuticals, LLC. "Due to the limited treatment options available, sialorrhea is an all-too-often poorly managed condition in pediatric patients suffering from neurologic disorders such as cerebral palsy. CUVPOSA®, the only FDA-approved treatment on the market, is an important advancement in the treatment of chronic severe drooling in children with neurologic disorders."
CUVPOSA® was approved by the FDA in July 2010 and has been commercially available in the U.S. since April 2011. It is the only FDA-approved treatment to reduce chronic severe drooling in pediatric patients (aged 3-16) with neurologic conditions associated with problem drooling. Sialorrhea is a common problem for individuals with neurologic conditions, especially children with cerebral palsy.
"The acquisition of CUVPOSA® is a promising addition to our neurology business and reflects our commitment to becoming a recognized leader in the treatment of movement disorders and related conditions in the U.S.," said Bill Humphries, president and chief executive officer of Merz, Inc. "Globally, the Merz Pharma Group is deeply committed to offering novel therapeutic options that address the large unmet medical needs that exists within the areas of Central Nervous System (CNS) and neurology."
Merz plans to continue the relationship with Diplomat Specialty Pharmacy and with Anda to help ensure caregivers have convenient access to CUVPOSA®.