The Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee discussed possible reasons why four Phase 3 clinical trials failed to demonstrate efficacy of proton pump inhibitors (PPIs) in treating gastroesophageal reflux disease (GERD) in children 1 to 12 months of age (see table).
At a meeting on Nov. 5, 2010, the committee also discussed future directions for study and supported the need for long-term safety information in children ages 1 month and older.
One reason the trials failed may be the differences between infant and adult GERD. Unlike adult GERD, most infant symptomatic GERD is not acid-related and should not be treated with a PPI unless the symptoms are proven to be acid-related.
The FDA Division of Gastroenterology Products is considering the impact of the discussion on future applications for premarket approval.
More information, including summary minutes and a transcript of the meeting, is available at www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/ucm195280.htm.