Replidyne said Tuesday its late-stage trial comparing faropenem medoxomil to both placebo and the antibiotic Ketek as a treatment for patients with acute exacerbation of chronic bronchitis is being stopped temporarily.
Faropenem, Replidyne's lead product candidate, is a new oral antibiotic being developed to treat respiratory and other community infections. The company said the study is being halted to consider excluding rival Ketek from the study, after a joint advisory committee meeting of the Food and Drug Administration's Anti-Infective Drug and Drug Safety and Risk Management committees said the risks of Ketek outweigh the benefits of using the drug to treat patients with AECB.
Federal health advisers said Dec. 15 that Ketek, made by Sanofi-Aventis, has been linked to reports of severe liver problems, including several deaths. Although Ketek's benefits outweigh its risks in treating pneumonia, they said, it may be too risky to be prescribed for less serious bacterial infections, such as bronchitis and sinusitis.
"We believe that stopping enrollment in this trial to consider the inclusion of Ketek in the study is the appropriate and responsible action at this time to consider the new scientific evidence presented at the recent FDA Advisory Committee meeting," said Kenneth J. Collins, president and CEO of Replidyne.
The company said that while this will delay results from this AECB study, it isn't expected to impact the total time needed to complete the clinical program required for submission to the FDA for approval to treat acute bacterial sinusitis, community-acquired pneumonia and AECB.
Replidyne also said the stoppage won't hurt the development of its pediatric clinical program for faropenem. The company had included Ketek in the study primarily for commercial competitive reasons.