# Development of an Ondansetron Transdermal Patch for Pregnancy-Induced Nausea and Vomiting

> **NIH NIH R43** · INTEGURX THERAPEUTICS LLC · 2024 · $333,284

## Abstract

Pregnancy-induced nausea and vomiting (PINV) afflicts 50-85% of all pregnancies, of which there
are 4 million each year in the US alone. Symptoms, often disabling and sometimes severe and
unremitting, occur in 80% of sufferers at random times throughout the day, and typically persist
throughout the first and early second trimester, and occasionally much longer. Currently available
treatments, of which only one is FDA-approved, require oral ingestion and retention of medication
multiple times daily, which can be challenging in the face of unrelenting nausea or vomiting.
The proposed SBIR Phase I project aims to complete the pharmaceutical development of a
transdermal dosage form designed to deliver the 5-HT3 antagonist anti-nauseant ondansetron to
treat pregnancy-induced nausea and vomiting (PINV). The final product will be a small patch
which is applied once or twice weekly. Following an initial lag period on the first day of dosing, the
product will deliver therapeutic quantities of drug continually throughout the period of application
without the need for oral administration.
Our product is intended to provide a safe, effective, and tolerable outpatient treatment for
PINV that avoids the oral route of administration entirely. It is based on a proprietary skin
penetration enhancement system which increases ondansetron absorption through the skin by
450-fold over unenhanced formulations. In a pre-IND meeting, we have obtained FDA’s guidance
on the path to regulatory approval. Once approved, this novel product will present a cost-effective,
convenient alternative to pregnant women suffering with PINV.
The aims of this proposed SBIR Phase I program for a transdermal ondansetron product are to:
1) complete optimization of product design, 2) produce pilot scale patches which conform to
product specifications, and 3) conduct IND-enabling dermal safety studies. Upon successful
completion of this program, an SBIR Phase II follow-up program will be proposed that will include
filing an IND, scale-up and manufacturing of clinical suppllies, and conducting a clinical
pharmacokinetics proof-of-concept study in healthy volunteers, while in parallel performing a
repeat-dose dermal toxicity study in minipigs to support longer-term clinical studies in pregnant
women.

## Key facts

- **NIH application ID:** 11008000
- **Project number:** 1R43HD116663-01
- **Recipient organization:** INTEGURX THERAPEUTICS LLC
- **Principal Investigator:** Gary Shangold
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $333,284
- **Award type:** 1
- **Project period:** 2024-09-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11008000

## Citation

> US National Institutes of Health, RePORTER application 11008000, Development of an Ondansetron Transdermal Patch for Pregnancy-Induced Nausea and Vomiting (1R43HD116663-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/11008000. Licensed CC0.

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