Glycopyrrolate Oral Solution
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Chronic drooling (sialorrhea) is a common dysfunction in children with neurologic disorders such as cerebral palsy. Glycopyrrolate oral solution, an anticholinergic agent, is the first drug treatment approved in the US for drooling in children with neurologic conditions. This article reviews the clinical efficacy and tolerability of glycopyrrolate oral solution in pediatric patients with neurologic conditions and provides an overview of the pharmacological properties of the drug.
In a phase III, randomized, double-blind, multicenter trial, children (aged 3–16 years;n=36) with problem drooling associated with neurologic conditions and receiving glycopyrrolate oral solution had a significantly (p<0.01) greater modified Teacher’s Drooling Scale (mTDS) response rate at 8 weeks (primary endpoint) than those receiving placebo (73.7% vs 17.6%).
At 24 weeks in an additional, noncomparative, phase III study, 52.3% of glycopyrrolate oral solution recipients (aged 3–18 years;n=137) had an mTDS response (primary endpoint); the response rate was consistently above 50% at all 4-weekly timepoints, aside from the first assessment at week 4 (40.3%).
In general, glycopyrrolate oral solution was well tolerated in clinical trials. The majority of adverse events were within expectations as characteristic anticholinergic outcomes.
Acknowledgments and Disclosures
The manuscript was reviewed by: M. Puzanovova, Department of Pediatrics, Vanderbilt Children’s Hospital, Nashville, TN, USA; E.A. Yeh, Department of Pediatrics (Neurology), University of Toronto, Hospital for Sick Children, Toronto, ON, Canada.
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.
- 3.US FDA. Cuvposa™ (glycopyrrolate oral solution): US prescribing information [online]. Available from URL: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022571s000lbl.pdf [Accessed 2012 Apr 5]
- 4.US FDA. Center for Drug Evaluation and Research medical review of glycopyrrolate oral solution (application number: 022571Orig1s000) [online]. Available from URL: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022571Orig1s000MedR.pdf [Accessed 2012 Apr 5]
- 13.Zeller RS, Lee HM, Cavanaugh PF, et al. Randomized Phase III evaluation of the efficacy and safety of a novel glycopyrrolate oral solution for the management of chronic severe drooling in children with cerebral palsy or other neurologic conditions. Ther Clin Risk Manag 2012; 8: 15–23.PubMedCrossRefGoogle Scholar