Pediatric Subcommittee Presentation on Pharmacologic Control of Drooling

5/21/01


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Table of Contents

Pediatric Subcommittee Presentation on Pharmacologic Control of Drooling

Issues for the Pediatric Subcommittee

Questions for the Pediatric Subcommittee

Division of Dermatologic and Dental Drug Products (DDDDP, HFD-540)

Agenda

Agenda (cont’d)

Autonomic Nervous System

Innervation of Salivary Glands

Reasons Drooling Requires Intervention

Other Cholinergic Effects

Summary

Summary (cont’d)

PPT Slide

PPT Slide

Drooling

Prevalence of Cerebral Palsy1

Prevalence of Drooling4

Reasons Drooling Requires Intervention

Reasons Drooling Requires Intervention

Methods Used to Control Drooling

Pharmacologic Control

Antimuscarinics

PPT Slide

PPT Slide

PPT Slide

Clinical Trials Necessary to Evaluate New Formulations

Clinical Studies Necessary to Determine Pediatric Dosing

PPT Slide

PPT Slide

Challenges of Conducting Clinical Trials in Children with Special Needs:

Efficacy Assessment

Efficacy Assessment

Safety Assessment

Safety Assessment

Conclusions

Author: Jill Randolph