Issue: March 2011
March 01, 2011
2 min read

FDA approves synthetic form of progesterone

Issue: March 2011
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Hydroxyprogesterone caproate, a synthetic form of the hormone progesterone, is now FDA approved to help reduce the risk for preterm delivery in pregnant women who have a history of spontaneous birth.

Pregnant women at risk for preterm delivery can receive a once-weekly injection of hydroxyprogesterone caproate (Makena) into the hip. Treatment should begin at 16 weeks and no later than 21 weeks gestation. The injections are indicated only for women who are carrying a single fetus and who have no other risk factors for pregnancy.

“Preterm birth is a significant public health issue in the United States,” Sandra Kweder, MD, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, said in a press release. “This is the first drug approved by the FDA that is indicated to specifically reduce this risk.”

It is estimated that half a million babies are born prematurely in the US each year.

The therapy was approved under the FDA’s accelerated approval regulations, which allow promising drugs to be approved based on a surrogate endpoint benefit that is reasonably likely to predict a clinical benefit. Under these regulations, the manufacturer must conduct additional studies to demonstrate that the drug does, in fact, have a clinical benefit. An international trial is ongoing to investigate whether there is also improvement in the outcome of babies born to women given hydroxyprogesterone caproate.

In a multicenter, randomized, double blind, clinical trial, 37% of pregnant women with a history of prior spontaneous preterm birth who were given hydroxyprogesterone caproate delivered before 37 weeks compared with 55% of women who served as a control group. Results of another study that evaluated the development of children born to mothers in the controlled trial showed that children aged 2.5 years to 5 years reached similar developmental targets, regardless of the mother’s treatment. This study is ongoing and will be followed by a similar infant follow-up study of up to 750 infants that is slated for completion in 2018.

Pain, swelling or itching at the injection site were the most common adverse effects reported with hydroxyprogesterone caproate. Serious adverse reactions were rare; there was a single report each of pulmonary embolism and an infection at the injection site.

The FDA originally approved hydroxyprogesterone caproate under the trade name Delalutin in 1956 for use in pregnant women. The original manufacturer requested withdrawal of Delalutin from the market in 2000 for reasons unrelated to safety.

The drug is sponsored by Hologic, Inc., based in Sunnyvale, Calif.

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