| FDA Announces Availability of a Draft Guidance, Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications | | | On December 1, 2020, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled "Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications." This draft guidance describes the FDA's recommendations regarding: (1) when clinical drug-drug interaction (DDI) studies with acid-reducing agents (ARAs) are needed; (2) the design of clinical DDI studies; (3) how to interpret study results; and (4) communicating findings in drug product labeling. ARAs such as antacids, histamine H2-receptor antagonists (H2 blockers), and proton pump inhibitors (PPIs) are widely used, and many of these drugs are available over the counter. ARAs can affect the solubility and dissolution characteristics of orally administered drug products by elevating gastric pH. As a result, concomitant administration of a drug with an ARA could alter the bioavailability of the drug, potentially resulting in a loss of efficacy for weak-base drugs or increased adverse events for weak-acid drugs. Consequently, there is an increased risk for clinically significant DDIs with concomitant administration of drugs with ARAs. Therefore, it is important to assess the susceptibility of an investigational drug to DDIs mediated by gastric-pH changes early in drug development, characterize the DDI effect with clinical studies when needed, and communicate the relevant findings in the drug product labeling. The "Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications" guidance is available at https://go.usa.gov/x7Hp5. Please refer to the draft guidance for more details. FDA is publishing this draft guidance to collect additional public comments. You may submit your comments regarding the draft guidance to the docket (Docket No. FDA-2020-D-1794) available at https://www.regulations.gov up to 90 days following publication in the FEDERAL REGISTER. This draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience and make your voice count. | | | The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and select Clinical Pharmacology Corner under Drugs. We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov. This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA. | | | |
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