Project Details

Mucoadhesive Atropine Gel for the Treatment of Sialorrhea in Children with Neurodisabilities

Venkata (Kash) Yellepeddi, PhD, RPh, DABCP

Summary

BACKGROUND: Sialorrhea, or chronic drooling, affects many children with cerebral palsy and other neurodisabilities. It can cause aspiration, pneumonia, skin injury, social stigma, and substantial daily burden for both children and their families. GAP: Despite these risks, no FDA-approved, child-specific atropine treatment exists for sialorrhea. Current off-label atropine eye drops can be difficult to dose, wash out quickly, and carry medication-error risks, while key pediatric pharmacokinetic and safety data remain undefined. HYPOTHESIS: We hypothesize that a mucoadhesive atropine gel designed for the mouth will provide safer, more predictable, and more effective control of drooling than current improvised approaches. We further hypothesize that model-informed dosing can identify a therapeutic window that improves symptoms while limiting side effects. METHODS: We will conduct a randomized, double-blind, two-period crossover study in 30 children aged 2–18 years with neurodisabilities and clinically significant sialorrhea. Participants will receive once-daily atropine gel at 0.01, 0.05, or 0.1 mg/kg for 7 days, with evaluation of drug exposure, drooling severity, safety, caregiver acceptability, and quality of life. RESULTS: In an FDA-regulated adult Phase I study, the gel showed favorable pharmacokinetics, slower absorption than eye drops, and no local or systemic adverse effects. Pediatric modeling further identified doses expected to remain above the minimum effective concentration while staying below established safety thresholds. IMPACT: This work could transform an unsafe off-label practice into the first pediatric-specific, noninvasive therapy for sialorrhea. By reducing treatment burden and supporting safer, more effective symptom control, it has the potential to improve health and quality of life for children with neurodisabilities and their caregivers. Website Link: https://medicine.utah.edu/faculty/venkata-k-yellepeddi