Glycopyrrolate (Cuvposa) is used to reduce saliva and drooling in children between 3 and16 years of age that have certain medical conditions that cause drooling. (medlineplus.gov)
Glycopyrrolate3
Cuvposa (also known as Glycopyrrolate) is an oral solution that was approved on July, 2010 by the U.S. Food and Drug Administration (FDA) as a treatment to reduce chronic drooling in children aged three to 16 years who suffer from neurological conditions (such as cerebral palsy). (pharmacology.org)
Glycopyrrolate (Cuvposa) is used to reduce saliva and drooling in children between 3 and16 years of age that have certain medical conditions that cause drooling. (optionrx.com)
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. (medicaldesignandoutsourcing.com)
CUVPOSA is an anticholinergic indicated to reduce chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). (nih.gov)
Systemic1
Meanwhile, the average time under pCPA consideration increased from 155 days in August to a high of 190 days in November, primarily due to four files remaining under consideration for 525 to 747 days: Cuvposa for chronic severe drooling, Benlysta for systemic lupus erythematosus, Onstryv for Parkinson's Disease and Idhifa for Acute Myeloid Leukemia. (morseconsulting.ca)
Drooling2
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. (medicaldesignandoutsourcing.com)
For these children and adolescents who exhibit excessive drooling, the availability of CUVPOSA™ offers an important advancement in therapy. (medicaldesignandoutsourcing.com)
Renal impairment: Use CUVPOSA with caution in patients with renal impairment. (nih.gov)
In addition, Cuvposa should not be administered to patients who are currently treated with solid oral doses of potassium chloride. (pharmacology.org)
Children1
The data from the clinical trials for Cuvposa indicated that 78 percent of the children administered this drug achieved pre-determined criteria for clinical improvement. (pharmacology.org)