Creating a skin patch to relieve nausea and vomiting during pregnancy
Development of an Ondansetron Transdermal Patch for Pregnancy-Induced Nausea and Vomiting
['FUNDING_SBIR_1'] · INTEGURX THERAPEUTICS LLC · NIH-11008000
This study is working on a new skin patch that delivers ondansetron to help pregnant people who are dealing with nausea and vomiting, making it easier for them to get relief without having to take pills.
Quick facts
| Phase | ['FUNDING_SBIR_1'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | INTEGURX THERAPEUTICS LLC (nih funded) |
| Locations | 1 site (CALIFON, UNITED STATES) |
| Trial ID | NIH-11008000 on ClinicalTrials.gov |
What this research studies
This research focuses on developing a transdermal patch that delivers ondansetron, a medication used to treat pregnancy-induced nausea and vomiting (PINV). The patch is designed to be applied once or twice a week, providing a continuous release of the medication without the need for oral ingestion, which can be difficult for those experiencing severe nausea. The project aims to enhance the absorption of ondansetron through the skin significantly, making it a more effective treatment option for pregnant individuals suffering from PINV. The research has already received guidance from the FDA on the regulatory approval process, indicating a clear path forward for the product's development.
Who could benefit from this research
Good fit: Ideal candidates for this research are pregnant individuals experiencing nausea and vomiting, particularly during the first and early second trimesters.
Not a fit: Patients who are not pregnant or those who do not experience nausea and vomiting during pregnancy may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could provide a more convenient and effective treatment option for pregnant individuals suffering from debilitating nausea and vomiting.
How similar studies have performed: While there are existing treatments for PINV, the transdermal delivery method being explored in this research is novel and has not been widely tested in this context.
Where this research is happening
CALIFON, UNITED STATES
- INTEGURX THERAPEUTICS LLC — CALIFON, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: SHANGOLD, GARY — INTEGURX THERAPEUTICS LLC
- Study coordinator: SHANGOLD, GARY
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.