Description
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Erosive Esophagitis: Developing Drugs for Treatment.” The draft guidance details recommendations on clinical trials for drugs being developed for the healing of erosive esophagitis (EE) and maintenance of healed EE in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
4Drugs with significant anticholinergic effects
Concomitant acid-reducing medications
Concomitant acid-reducing medications
Licensed under section 351 of the Public Health Service Act.
Stakeholders
2Assist sponsors in the nonclinical evaluation
Entity responsible for submitting applications under section 524B
Regulatory Context
Regulatory Activities
2Administering survey instruments in a clinical trial at screening and/or exit visits; obtaining patient feedback regarding various topics throughout a trial
The process of developing drugs for treatment of EE.
Document Types
1Instrument used to assess symptoms like heartburn and regurgitation
Attributes
5Mucosal break involving at least 75% of the esophageal circumference.
Mucosal break continuous between tops of two or more mucosal folds involving less than 75% circumference.
Mucosal break more than 5 mm long not extending between tops of two mucosal folds.
Mucosal break no longer than 5 mm not extending between tops of two mucosal folds.
Statistical parameter requiring strong control when testing multiple endpoints
Technical Details
Substances
2Subjects testing positive for this during screening should be excluded
The drug being tested in clinical trials.
Testing Methods
3The procedure used to apply the Los Angeles Classification criteria.
Method used to document healed EE and assess primary endpoints
Used to define EE by the presence of superficial esophageal erosions.
Clinical Concepts
10Anatomical reference used to distinguish between Grade C and Grade D esophagitis.
The primary clinical observation used to define grades A through D in the LA Classification.
Potential risk identified with long-term acid suppression
Potential risk identified with long-term acid suppression
Coexisting disease affecting the esophagus
Exclusion criterion for the trial
Potential progression from untreated erosive esophagitis.; Exclusion criterion for the trial
Complication of untreated erosive esophagitis.
Spectrum of acid-related disorders including EE.
The primary disease state addressed by the guidance.; Primary disease state being treated in the clinical trials; The clinical condition being assessed via endoscopic grading.
Standards & References
External Standards
2A system used for the endoscopic assessment and grading of erosive esophagitis.
System used to define and grade EE severity at baseline endoscopy.
Specifications
2Los Angeles classification used to assess disease severity
Spectrum of disease severity for enrollment criteria.
ICH References (1)
Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- DSCSA Implementation: Product Tracing Requirements — Compliance Policy
- E6(R3) Good Clinical Practice: Annex 2
- Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry: Guidance for Industry
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development
- Botanical Drug Development: Guidance for Industry
- Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
- Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2