Columbia/Watson gel did not work in U.S.: FDA review

Columbia Laboratories' and Watson Pharmaceuticals' gel for reducing the risk of premature birth did not work for U.S. women, U.S. health reviewers said on Tuesday, sending shares of the companies tumbling.

The Food and Drug Administration reviewers said the gel's efficacy was "a major concern" and asked an advisory panel to consider whether the company should conduct more U.S. clinical trials.

The vaginal gel, which contains the hormone progesterone, is meant for women with a short cervix, who have a higher risk of premature birth.

Preterm birth affects 10 to 12 percent of all pregnancies in the United States, and babies born early have a higher risk of early death and long-term health and developmental problems.

The reviewers' comments were posted on the FDA's website on Tuesday. On Friday, an FDA panel of outside experts will vote on whether the agency should approve the drug, and the FDA will make a final decision by February 26.

Prochieve® (progesterone gel) is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system, which is contained in single use, one piece polyethylene vaginal applicators. The carrier vehicle is an oil in water emulsion containing the water swellable, but insoluble polymer, polycarbophil. The progesterone is partially soluble in both the oil and water phase of the vehicle, with the majority of the progesterone existing as a suspension. Physically, Prochieve® has the appearance of a soft, white to off-white gel.

Last year, Columbia and Watson said that in trials, their gel helped cut the risk of premature birth by almost 45 percent for women worldwide.

Prochieve Gel is used for:

Supplementing or replacing progesterone in infertile women with progesterone deficiency. It is also used in certain women who do not menstruate and have not responded to lower strengths of Prochieve Gel. It may also be used for other conditions as determined by your doctor.

Prochieve Gel is a hormone. It works by preparing the uterus (womb) for implantation of a fertilized egg and protecting the lining of the uterus. It is also needed for the maintenance of a healthy pregnancy.
Do NOT use Prochieve Gel if:

you are allergic to any ingredient in Prochieve Gel
you have cancer of the breast, ovary, lining of the uterus, cervix, or vagina; a history of blood clots or clotting problems; vaginal bleeding of unknown cause; or liver disease; or you have had a stroke, a recent miscarriage, or bleeding in the brain

Contact your doctor or health care provider right away if any of these apply to you.

But the FDA staff said the drug's efficacy for U.S. women was not statistically significant. The staff also said the overall trial results may have been influenced by the drug's success in countries such as Belarus and South Africa.