Drugs

Guide on Developing Drugs to Treat Erosive Esophagitis

FDA has posted a draft guidance entitled “Erosive Esophagitis: Developing Drugs for Treatment” that outlines recommendations for the clinical development of drugs to treat erosive esophagitis (EE) in adults. It provides a framework for drugmakers designing trials to evaluate therapies for both the healing of EE and the maintenance of healed EE.

Erosive esophagitis, often associated with gastroesophageal reflux disease (GERD), is a condition in which the lining of the esophagus becomes inflamed and damaged by stomach acid. While current treatments are available, the draft guidance is intended to ensure that future therapies are rigorously evaluated for safety and effectiveness, according to the agency.

FDA recommends that sponsors use randomized, double-blind, active-comparator trial designs to demonstrate either noninferiority or superiority to approved therapies. Sponsors may propose placebo-controlled studies, but the agency emphasizes the need for detailed discussions on trial design, eligibility, and patient monitoring.

The guidance also outlines expectations for trial structure, including:

Timing of efficacy assessments based on a drug’s mechanism of action and expected onset of benefit.
Prespecified endoscopic evaluations to confirm healing during the trial.
Rerandomization of patients whose EE has healed into maintenance trials lasting at least six months.
Clear instructions that participants should not change diet or lifestyle habits that affect EE symptoms during the course of the study.

The recommendations apply only to adult EE patients, and FDA says they do not cover related conditions such as nonerosive GERD, Barrett’s esophagus, Zollinger-Ellison syndrome, or pediatric EE.

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