Replidyne Halts Faropenem. U.S. firm Replidyne said Tuesday it has temporarily halted its study comparing faropenem to Ketek, due to the latter drug’s safety issue.
The company said it has been conducting a phase 3 clinical trial comparing faropenem medoxomil to placebo and to the antibiotic Ketek in patients being treated for acute exacerbation of chronic bronchitis (AECB).
Replidyne said it has put that study on hold while it considers whether to exclude from the trial the Ketek treatment arm, in light of recent data linking the antibiotic to liver damage.
The company said it made the decision based on the recommendations of an FDA advisory panel issued in mid-December that the risks of Ketek outweigh the benefits of using the drug for the treatment of patients with AECB.
We believe that stopping enrollment in this trial to consider the inclusion of Ketek
“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 Collins, president and CEO of Replidyne.
Collins noted that, while the temporary suspension of the trial would cause some delay, he added, “we do not expect that it will impact the total time to complete the clinical program.”
Collins also said the decision would not impact the company’s development of its pediatric clinical program for faropenem.