QDIS Blog

Replidyne is testing its antibiotic Faropenem in phase III clinical trials against Ketek and placebo for treatment of acute exacerbation of chronic bronchitis )AECB). However, due to the joint Advisory Committee meeting of the FDA’s Anti-Infective Drug and Drug Safety and Risk Management committees where concerns about the use of Ketek for this indications. This means they will stop the trial, look into eliminating the Ketek arm and then restart the trial after making changes to the number of patients to be enrolled and possibly considering another comparator.

Faropenem Phase III Clinical Trial Stopped to Consider Exclusion of Ketek Comparator

Replidyn has already received a non-approvable from the FDA back in Oct 2006.

U.S. Food and Drug Administration Issues Non-Approvable Letter for Faropenem

What is somewhat interesting in this respect is that it seems to reflect a change in FDA policy regarding superiority studies in particular with antibiotics and especially for the AECB indication.. In the past, the FDA has not required this for antibiotics and the studies done on Faropenem were non-inferiority designs. Replidyne may be getting caught in the changes where the FDA is now looking into placebo controlled studies for antibiotics. This new study which is being stopped to consider exclusion of Ketek, was planned as a placebo controlled superiority study. However, now the question is do they continue with the comparator Ketek. I think it likely that they will exclude the Ketek arm and likely choose another comparator. This means even more delays.

I do feel for Replidyne and think they have gotten caught up in the changing climate and this is likely not their fault. My concern though is that it may mean even more companies do not get into development of anti-infectives, an area of vital need now in my opinion.

Other Resources
Faropenem - Wikipedia, the free encyclopedia
Replidyne (page on Faropenem Medoxomil)Zoom structure
CID 636379 — PubChem Compound Summary

Technorati Tags: Faropenem, Ketek, Replidyne, telithromycin

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