# Pharmacological Approaches for Transepithelial Delivery of Therapeutics to the Vocal Folds

> **NIH NIH R01** · SAINT LOUIS UNIVERSITY · 2024 · $602,131

## Abstract

PROJECT SUMMARY/ABSTRACT
The lifetime prevalence of voice disorders in the adult United States population is 30% with point prevalence
rates of 6.6% to 7.5%1,2. Point prevalence and census estimates suggest that nearly 20-23 million adults may
experience dysphonia annually, with the cost of treatment and lost wages approaching $13 billion dollars3. These
annual direct costs are comparable to those associated with chronic obstructive pulmonary disease, asthma,
diabetes, and allergic rhinitis3. Thus, improving the care of patients with voice disorders remains a significant
public health need. To address this need, over the last 17 years, our research program has initiated systematic
studies in the understanding of the cellular and molecular pathophysiology underlying vocal fold tissue changes.
Our studies to date have provided critical new insights into the cellular and molecular sequalae regulating vocal
fold permeability. Over the last 5 years, we have focused our studies on the safety and efficacy of
pharmacological treatments for voice disorders. Our preliminary data have revealed mechanisms regulating
permeability of the vocal fold epithelial barrier from a class of steroid hormones ubiquitously found in most cells
in the human body. Beyond the anti-inflammatory actions of these glucocorticoids, emerging evidence in our
laboratory supports a role for glucocorticoids in the regulation of the vocal fold paracellular pathway. These
preliminary data have led to an overarching hypothesis that vocal fold epithelial permeability can be
selectively regulated using pharmacological approaches that target the paracellular pathway. This novel
treatment concept provides exciting new possibilities in the management of vocal fold disease by providing
pharmacologic access to the subepithelial space–and a means for transepithelial delivery of commonly available
fillers and biomaterials to the vocal folds. Over the next five years, we will converge our next series of
studies on the selective regulation of vocal fold epithelial permeability using a combination of in vitro
and in vivo experiments. The current R01 builds on a programmatic series of investigations which have
provided the necessary preliminary data to support selective permeability of the vocal fold paracellular pathway.
The goal of this R01 proposal is to empirically quantify the effects of methylprednisolone on selective regulation
of the vocal fold paracellular pathway. These pre-clinical studies are necessary to provide indications for use,
safety, and the demonstration of therapeutic efficacy prior to human trials. The specific deliverable upon project
completion will be the preliminary studies necessary for rigorous testing in phase I/II/III human trials.

## Key facts

- **NIH application ID:** 10596214
- **Project number:** 5R01DC019566-03
- **Recipient organization:** SAINT LOUIS UNIVERSITY
- **Principal Investigator:** Bernard Rousseau
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $602,131
- **Award type:** 5
- **Project period:** 2022-04-01 → 2028-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10596214

## Citation

> US National Institutes of Health, RePORTER application 10596214, Pharmacological Approaches for Transepithelial Delivery of Therapeutics to the Vocal Folds (5R01DC019566-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10596214. Licensed CC0.

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