Louisville-based Replidyne Inc. has halted a study on its lead drug, the oral antibiotic faropenem medoxomil, after a comparison drug was deemed unsafe, the company said Tuesday.
Replidyne was enrolling subjects to test faropenem against a placebo and against Ketek, an antibiotic already on the market from Sanofi Aventis, in the treatment of chronic bronchitis.
A Food and Drug Administration advisory group said Dec. 15 that the risks of Ketek in treating bronchitis outweighed the benefits.
Replidyne stopped the study until it decides whether to find a replacement for Ketek or move forward against a placebo only.
While the removal of Ketek will complicate the trial, which was scheduled to wrap up early next year, it also creates an opportunity.
“It means that when we get this drug approved, the biggest competitor won’t be such a factor,” said Sabrina Oei, Replidyne’s director of investor relations.
Replidyne’s stock took a hit in late October after the FDA asked for additional testing on faropenem, which is being tested as a treatment for bronchitis, pneumonia, sinusitis and skin infections.
Replidyne is developing the drug, its first, with Forest Laboratories Inc. of New York.
Shares of Replidyne closed down 5 cents Tuesday, to $6.25.
Company officers and insiders were eligible to sell their shares Tuesday, the first time since Replidyne went public June 28 at $10 a share.
Staff writer Aldo Svaldi can be reached at 303-954-1410 or asvaldi@denverpost.com.
