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Shionogi Announces Commercial Availability of CUVPOSAâ„¢ (Glycopyrrolate) Oral Solution for Pediatric Chronic Severe Drooling Associated With Neurologic Conditions

April 7, 2011 By Bio-Medicine.Org

FLORHAM PARK, N.J., April 7, 2011 /PRNewswire/ — 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 number

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SOURCE

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