BioCentury
ARTICLE | Clinical News

Doribax: Phase III halted

January 16, 2012 8:00 AM UTC

Johnson & Johnson said in a Dear Healthcare Professional letter that it terminated a double-blind, international Phase III trial after an interim analysis showed a numerically higher mortality and a numerically poorer clinical cure rate in patients treated with Doribax compared with imipenem/cilastatin. Specifically, in 274 patients diagnosed with VAP, the 28-day all cause mortality rate in the microbiological intent-to-treat (MITT) population was 21.5% for patients receiving a 7-day course of Doribax vs. 14.8% for patients receiving a 10-day course of imipenem/cilastatin. Additionally, Doribax led to lower clinical cure rates vs. imipenem/cilastatin in the MITT population (45.6% vs. 56.8%) and in the microbiologically evaluable (ME) population (49.1% vs. 66.1%). The trial was slated to enroll 524 adults hospitalized for >=5 days who had been diagnosed with VAP.

FDA also issued a statement noting that Doribax is still considered safe and effective for its approved indications of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). J&J has rights to Doribax from Shionogi, which markets the product as Finibax in Japan. ...