Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed
This grant aims to identify drug and formulation factors causing alcohol-induced rapid release from modified-release drugs, improving testing and development for safer generics.
Funder: Food and Drug Administration
Due Dates: Forecasted (no due date posted)
Funding Amounts: $250,000 (one award; cooperative agreement; typically 1 year)
Summary: Supports research to identify drug and formulation factors causing alcohol-induced rapid release (“dose dumping”) from modified-release oral drugs, to improve testing and regulatory guidance for safer generics.
Key Information: Clinical trials are not allowed; opportunity is currently forecasted, not open.
Description
This FDA grant opportunity seeks research to identify drug-related and formulation-related factors that contribute to alcohol dose dumping (ADD) in modified-release (MR) oral drug products. Alcohol dose dumping refers to the unintended, rapid release of a drug from an MR formulation when exposed to alcohol, which can lead to severe side effects or death. The project aims to:
- Develop tools to facilitate the creation of MR generic drug products with low ADD potential.
- Support regulatory decision-making for these products.
- Provide evidence to help the FDA develop more specific recommendations for demonstrating low or comparative ADD risk in MR oral drugs containing high-risk active ingredients.
The research is intended to address challenges in harmonizing ADD assessments globally, as current U.S. and European guidelines differ in alcohol concentrations used for testing, and in vitro results may not always predict in vivo behavior.
