Pediatric Drugs

, Volume 14, Issue 4, pp 263–269 | Cite as

Glycopyrrolate Oral Solution

For Chronic, Severe Drooling in Pediatric Patients with Neurologic Conditions
Adis Drug Profile

Abstract

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.

Notes

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.

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Copyright information

© Springer International Publishing AG 2012

Authors and Affiliations

  1. 1.AdisAucklandNew Zealand

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