WASHINGTON (AP) – Federal drug reviewers announced that Columbia Laboratories hormone-based gel appears to be ineffective for preventing premature birth.
The Food and Drug Administration said in an online review that Columbia Labs’ drug failed to show a significant reduction in preterm birth among U.S. women tested in the company’s trial. The company has submitted the progesterone-based gel, called Prochieve, as a treatment to reduce instances of non-full-term births by women with abnormally short cervixes. The company estimates the problem affects 10% to 12% of all pregnancies in the U.S.
The FDA will ask a panel of outside experts to vote on the effectiveness and safety of the drug. The FDA is not required to follow the group’s advice, though it often does. The FDA will make its final decision on the drug later this year.
Columbia is co-developing Prochieve with generic and specialty drugmaker Watson Pharmaceuticals Inc.
Date: January 17, 2012
Source: Associated Press
