Cellegy’s Headache: FDA Says Analgesic Use May Have Skewed Cellegesic Efficacy Results
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA advisory committee preview documents question whether concomitant acetaminophen use in trials of the nitroglycerin ointment could be responsible for a small reduction in anal fissure pain.
You may also be interested in...
Missing Clinical Trial Data: "Mixed Model" Approach Gains Ground At FDA
Clinical trial sponsors should adopt a mixed statistical model to cope with missing data rather than relying on the "last observation carried forward" model that was formerly perceived as regulators' favorite
Missing Clinical Trial Data: "Mixed Model" Approach Gains Ground At FDA
Clinical trial sponsors should adopt a mixed statistical model to cope with missing data rather than relying on the "last observation carried forward" model that was formerly perceived as regulators' favorite
Cellegy Seeks A Buyer Or Partner For Cellegesic Following FDA “Approvable” Letter
"Approvable" letter indicates the need for additional studies to provide more evidence of the efficacy of the nitroglycerin ointment for anal fissures.