The U.S. Food and Drug Administration (FDA) is announcing revisions of a draft guidance for industry titled, “Gastroparesis: Clinical Evaluation of Drugs for Treatment.” This guidance revises the draft guidance for industry of the same name issued in July 2015. Changes from the previous draft reflect FDA’s current thinking on the development of clinical outcome assessment measures and statistical considerations for use of those measures to assess primary and secondary efficacy endpoints of clinical trials for gastroparesis.
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of idiopathic and diabetic gastroparesis. The guidance discusses clinical trial design, trial populations, approach for outcome assessment measures, endpoints and statistical consideration. There is an unmet need for development of safe and effective chronic therapies to treat patients with gastroparesis. The FDA intends the revisions to the guidance to provide a path forward for drug development for gastroparesis.
The FDA seeks comments and suggestions on this guidance. For more information, please refer to the guidance.
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