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The Food and Drug Administration (FDA) has announced a funding opportunity, designated as FOR-FD-24-006, focused on the identification of drug-related and formulation-related factors that result in alcohol dose dumping of modified release (MR) oral drug products. This cooperative agreement is critical in addressing the potential risks associated with modified release oral drugs, especially when inadvertently exposed to alcohol, leading to severe side effects due to rapid drug release. The grant falls under categories such as agriculture, consumer protection, and food and nutrition, highlighting its significance in safeguarding public health.
Eligibility for this funding opportunity is extensive, including various entities like educational institutions, government bodies, non-profits, and private sector organizations. The primary aim of this research is to develop tools that can facilitate the creation of MR generic drug products with a low potential for alcohol dose dumping. Additionally, the research seeks to support regulatory decision-making during the assessment of such products and provide evidence that enables the FDA to develop more specific recommendations for demonstrating a low or comparative potential of alcohol dose dumping. With an award ceiling of $250,000, this grant represents a crucial step in enhancing the safety and efficacy of MR oral drug products, particularly in contexts where alcohol interaction can lead to significant health risks. This initiative is a key part of the FDA’s commitment to ensuring the safe use of pharmaceuticals and protecting patients from potential hazards associated with drug and alcohol interactions.
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Opportunity ID: 351128
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General Information
| Document Type: | Grants Notice |
| Opportunity Number: | FOR-FD-24-006 |
| Opportunity Title: | 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 |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | |
| Expected Number of Awards: | 1 |
| CFDA Number(s): | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Forecast 1 |
| Forecasted Date: | Nov 24, 2023 |
| Last Updated Date: | Nov 24, 2023 |
| Estimated Post Date: | |
| Estimated Application Due Date: | |
| Estimated Award Date: | |
| Estimated Project Start Date: | |
| Fiscal Year: | 2024 |
| Archive Date: | |
| Estimated Total Program Funding: | |
| Award Ceiling: | $ 250,000 |
| Award Floor: | $ 250,000 |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities State governments Independent school districts Small businesses Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments For profit organizations other than small businesses Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH or FDA will not accept: •A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. •A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. •An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications). |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Modified release (MR) oral drug products are considered to have a high risk for alcohol dose dumping (ADD) because they contain large quantities of drug(s), designed to release over a prolonged period of time. Accidental exposure of these products to alcohol can result in the relatively rapid release of large quantities of drug with severe side effects, including death. To mitigate this risk, the FDA recommends conducting an in vitro alcohol dose dumping assessment in 0%, 5%, 20%, and 40% alcoholic dissolution media for all prospective generic versions of MR oral drug products.
To date, ADD assessments have not been harmonized globally. For instance, the U.S. FDA recommends testing up to 40% alcoholic media while the European Medicines Agency recommends testing up to 20% alcoholic media. This type of difference can present a challenge for formulators designing products for multiple markets, as historical data has shown release from MR oral products do not always follow a linear response (either increasing or decreasing) to increasing alcohol concentrations. In addition, interpretation of an ADD assessment may be limited by the inability of the test to predict in vivo behavior. The purpose of this research is to develop tools that 1) facilitate the development of MR generic drug products that have a low potential for ADD, 2) support regulatory decision making during the assessment of such products, and 3) provide evidence that enables FDA to develop more specific recommendations for efficiently demonstrating a low or comparative potential of alcohol dose dumping for MR oral drug products containing high risk drugs. |
| Link to Additional Information: | |
| Grantor Contact Information: |
Terrin Brown
Grantor 2403387494
|
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