2017-08-21 20:48:53 UTC

Innovation is Needed in Functional Dyspepsia Drug Development

Aug. 22, 2017

Functional dyspepsia is not a one-size-fits-all condition, which is a challenge for drug development. But promising new trials are underway.

At the 2016 AGA Drug Development Conference, several patient advocates bravely took to the microphone to share with gastroenterologists, FDA and pharmaceutical companies the struggles that patients with functional dyspepsia face on a daily basis. They explained that there is much patient dissatisfaction with the diagnostic label of functional dyspepsia and with current treatment options. These and other discussions at the conference resulted in the AGA Center for Diagnostics and Therapeutics developing a new white paper to update you on the current state of treatments and next steps for drug development.

The white paper, available in the August issue of Clinical Gastroenterology and Hepatology, provides an overview of current treatment options for functional dyspepsia and recommends future directions for drug development. Here are highlights from the paper.

1. Although there are currently no FDA-approved medicines for functional dyspepsia, several therapeutic approaches can be helpful, including treatment of H. pylori infection, acid suppression with a proton pump inhibitor, use of a prokinetic agent or a low dose of a tricyclic antidepressant. Functional dyspepsia is not a one-size-fits-all condition.

2. Clinical trials in functional dyspepsia are complicated by variable symptom profiles and overlap with other GI conditions (i.e., reflux disease, gastroparesis and irritable bowel syndrome). Enrollment into different trials may have been unduly restrictive or inclusive in the past. Patients with overlapping syndrome need not be excluded from trials in functional dyspepsia, but clear criteria must be established.

3. A validated patient-reported outcomes measure is urgently needed for future clinical trials. The recent development of the Functional Dyspepsia Diary represents an important advance in this area.

Here’s the good news to tell your patients: clinical trials are underway looking at specific subtypes of functional dyspepsia and examining novel pharmacological approaches. Visit the AGA PatientINFO Center for resources you can provide to your patients with dyspepsia to help them understand and manage their condition.

Learn more about the AGA Drug Development Conference and the resulting white papers in this editorial by conference co-chairs Colin Howden, MD, AGAF, and Nimish Vakil, MD, AGAF, or view the related white papers on eosinophilic esophagitis, gastroparesis and GERD.

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