FDA panel votes down preterm birth gel

Associated Press

WASHINGTON (AP) — A panel of government health experts voted Friday that Columbia Laboratories' hormone-based gel failed to show effectiveness for preventing premature birth.

The Food and Drug Administration's panel of reproductive health physicians voted 13-4 against the company's progesterone-based gel, called Prochieve.

Columbia Laboratories submitted the drug 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 percent of all pregnancies in the U.S. and accounts for 34 percent of all infant deaths in the U.S.

But the majority of the FDA's panelists said the company's single trial did not show a statistically significant reduction in preterm birth, particularly among U.S. women.

"With such a significant disease associated with mortality and morbidity we don't want to provide things that aren't truly efficacious," said panelist Dr. Kathleen Hoeger of the University of Rochester Medical Center.

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, based in Livingston, N.J., is co-developing Prochieve with generic and specialty drugmaker Watson Pharmaceuticals Inc. of Parsippany, N.J.

Shares of Columbia Laboratories Inc. were halted Friday in anticipation of the panel vote. The stock lost half of its value Tuesday after FDA staff scientists posted a critical review of the company's drug.