Description
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment.” The draft guidance details FDA’s recommendations on the clinical trials for drugs being developed for the treatment of symptomatic nonerosive gastroesophageal reflux disease (sGERD) 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
1Licensed under section 351 of the Public Health Service Act.
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Regulatory Activities
2Recommended trial design for sGERD drugs
Development program for drugs intended for sGERD treatment
Document Types
1Instrument used to assess symptoms like heartburn and regurgitation
Attributes
2Statistical parameter requiring strong control when testing multiple endpoints
Requirements for enrolling subjects in sGERD trials
Technical Details
Substances
5Drug type that may alter the minimum acceptable size of the safety database
Drugs with significant anticholinergic effects
Acid-reducing medications
Acid-reducing medications generally not permitted as concomitant use
Subjects testing positive for this during screening should be excluded
Testing Methods
2Method used to document healed EE and assess primary endpoints
Used to define EE by the presence of superficial esophageal erosions.
Clinical Concepts
6Coexisting disease affecting the esophagus
Pathological hypersecretory condition excluded from guidance
Potential progression from untreated erosive esophagitis.; Exclusion criterion for the trial
Condition excluded from the scope of this specific guidance
Primary symptom and inclusion criterion for sGERD trials
Target disease for drug development guidance
Identified Hazards
Hazards
2Potential risk identified with long-term acid suppression
Potential risk identified with long-term acid suppression
Standards & References
Specifications
1Primary efficacy endpoint defined as a 24-hour period with no heartburn
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