Johnson & Johnson stops Doribax trial; reportedly agrees Risperdal settlement

The US Food and Drug Administration says that a recent clinical trial with Doribax (doripenem) being conducted by health care giant Johnson & Johnson’s (NYSE: JNJ) Janssen subsidiary was stopped early because of significant safety concerns.

This trial, which was evaluating the effects of Doribax on treatment of patients with ventilator-associated pneumonia, demonstrated excess mortality and a numerically poorer clinical cure rate among subjects treated with Doribax compared to those treated with imipenem-cilastatin. FDA is reviewing the trial results and will communicate any new information that results from this investigation.

Patients in the study who received Doribax had a 6.7% higher rate of death from any cause than those getting an alternative. Patients taking Doribax also had an 11.2% lower rate of being cured than patients getting imipenem-cilastatin, the generic version of Merck & Co Inc's Primaxin.