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The purpose of this guidance is to assist sponsors in clinical drug development for the treatment of adults with duodenal ulcers caused by Helicobacter pylori (H. pylori) for the reduction of duodenal ulcer recurrence. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs to support antimicrobial-containing H. pylori treatment regimens. This guidance intends to serve as a focus for continued discussions among the Division of Special Pathogen and Transplant Products, pharmaceutical sponsors, the academic community, and the public. As the science of this indication evolves, this guidance may be revised as new information accumulates.
This guidance pertains to development of drugs for the treatment of adults with duodenal ulcers. It does not address treatment of children, or those with other conditions also associated with H. pylori, including gastric ulcers and non-ulcer dyspepsia. If sponsors are interested in pursuing an indication for the treatment of patients with other conditions associated with H. pylori infection or other endpoints not mentioned in this guidance, they are encouraged to discuss their proposals with the division. Sponsors desiring to pursue an indication for ulcers caused by clarithromycin-resistant organisms should discuss the types of data needed to support such a claim with the division early in drug development.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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