FDA Releases New Guidance for Clinical Evaluation of Irritable Bowel Syndrome Drugs

Posted 30 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released final guidance for industry to assist sponsors looking to develop drugs to treat patients suffering from irritable bowel syndrome (IBS).

The 30 May guidance, Guidance for Industry on Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment, covers general IBS symptoms and addresses two sub-sets of IBS which primarily result in diarrhea (IBS-D) and constipation (IBS-C), which FDA said have unique considerations not addressed in existing guidance.

While FDA said it would prefer to see a "well-defined and reliable patient-reported outcomes (PRO) instruments that measure the clinically important signs and symptoms associated with each IBS subtype," such an endpoint does not yet exist, making clinical evaluation of treatments difficult.

Rather than wait for instruments capable of definitively measuring symptoms to be created, FDA said it was moving ahead to offer guidance in the face of "great need" for effective IBS therapies. The guidance notes PROs can be used as primary endpoints for clinical studies, and makes study design recommendations to take provisional PROs into account.

In the meantime, FDA said it is working with the Critical Path Institute (C-Path) and its own qualification process to develop instrumentation and other validated drug development tools. (DDTs)

The final guidance also makes a number of changes to draft guidance issued in March 2010, including the addition of a randomized withdrawal design, the clarification of trial endpoints intended to treat a single symptom of IBS, modified trial entry criteria from patients suffering from only IBS-D, and new definitions for several symptoms.

Read more:

Guidance for Industry; Availability: Irritable Bowel Syndrome -- Clinical Evaluation of Drugs for Treatment

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