Mamas on Bedrest: FDA Approves Drug to Curb Risk for Preterm Birth!!

February 9th, 2011

First Drug Specifically Approved to Reduce the Risk of Preterm Labor.

On February 4, 2011, The US Food and Drug Administration approved hydroxyprogesterone caproate injection, Trade name Makena, to reduce the risk for preterm delivery before 37 weeks of pregnancy in women with singleton pregnancy and a history of at least 1 spontaneous preterm birth. This is the first drug approved specifically to reduce this risk.

The drug, a synthetic form of the hormone progesterone, is not intended for use in women with a multiple pregnancy or other risk factors for preterm birth.

Makena “Fast Tracked” by the FDA

The FDA approved Makena under the agency’s accelerated approval regulations that allow promising drugs to be approved based on a surrogate endpoint benefit (in this case, reducing the risk for preterm delivery) that is reasonably likely to predict a clinical benefit. The manufacturer will be required to conduct additional studies to demonstrate that the drug does, in fact, have a clinical benefit.

The FDA reviewed data on the safety and effectiveness of Makena in a multicenter randomized double-blind study sponsored by the National Institutes of Health. The study involved 463 women who were pregnant with a single fetus and had a history of a prior spontaneous preterm birth.

According to the FDA, of the women treated with Makena, 37% delivered early (before 37 weeks) compared with 55% of women in the control group.

Dosage and Administration

Makena is administered once a week by intramuscular injection. Treatment should begin at 16 weeks — and no later than at 21 weeks — of pregnancy and continue until 37 completed weeks or delivery.

The most common adverse effects reported with Makena in trials to date include pain, swelling, or itching at the injection site; hives; nausea; and diarrhea. Serious adverse reactions were rare; there was a single report each of pulmonary embolism and an infection at the injection site.

Makena will be manufactured by Baxter Pharmaceuticals for KV Pharmaceutical/Ther-Rx Corporation. Ther-Rx Corporation will market the drug.

According to Ther-Rx Corporation, Makena will be available for prescribing in early March. Makena is a specialty injectable and will not be available in retail pharmacies. Instead, Makena will be available through a network of specialty pharmacies and distributors that specialize in distributing specialty injectables and will be express mailed directly from the pharmacy/distributor to the healthcare provider or to the patient, depending on the preferred location for administration of weekly injection.

This is a Summary of a MedScape News Report.

Leave a Reply

Your email address will not be published. Required fields are marked *