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

id: 351128
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opportunityNumber: FOR-FD-24-006
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opportunityTitle: 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
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revision: 1
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agencyDetails: {"code":"FDA","seed":"HHS-FDA","agencyName":"Food and Drug Administration","agencyCode":"HHS-FDA","topAgencyCode":"HHS"}
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owningAgencyCode: HHS-FDA
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cfdas: [{"id":415636,"opportunityId":351128,"cfdaNumber":"93.103","programTitle":"Food and Drug Administration Research"}]
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forecastDesc: <p>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.</p> <p><br></p> <p>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.&nbsp;</p> <p><br></p> <p><span style="color: black;">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.&nbsp;</span></p>
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applicantTypes: [{"id":"00","description":"State governments"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"05","description":"Independent school districts"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"23","description":"Small businesses"},{"id":"04","description":"Special district governments"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"20","description":"Private institutions of higher education"},{"id":"99","description":"Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled \"Additional Information on Eligibility\""},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"},{"id":"01","description":"County governments"},{"id":"02","description":"City or township governments"}]
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applicantEligibilityDesc: 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:&bull;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.&bull;A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.&bull;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).
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fundingInstruments: [{"id":"CA","description":"Cooperative Agreement"}]
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fundingActivityCategories: [{"id":"AG","description":"Agriculture"},{"id":"CP","description":"Consumer Protection"},{"id":"FN","description":"Food and Nutrition"}]
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awardFloor: 250000
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awardCeiling: 250000
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costSharing: false
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lastUpdatedDate: Nov 30, 2023 04:00:41 PM EST
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status: forecasted
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