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New Drug For Preterm Birth

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New Drug For Preterm Birth

Makena reduces the risk of preterm birth in women with a history of premature delivery…

The FDA has approved a new injectable drug that reduces the risk of preterm birth in women with a history of premature pregnancy. When the drug, known as Mekena, goes on sale, it will be the first time in the last 11 years since such a medication has been available.

Manufactured by Baxter Pharmaceuticals for K-V Pharmaceutical/Ther-Rx Corporation, Makena contains the active chemical hydroprogesterone caproate. In clinical trials the drug has been shown to be effective in reducing the risk of preterm birth before 37 weeks in women who have had at least one premature delivery, however the FDA said that the drug should not be used in women with multiple pregnancies, or in those who have other risk factors.

The FDA says the drug will be administered via weekly injections performed by a healthcare provider with treatment beginning between the 16th and 21st week of pregnancy. Because of the promising results of Mekena’s clinical trials, the drug has had a relatively short development and testing phase as it was approved under the FDA’s accelerated approval regulations – a program which allows effective treatments to reach the market quickly.

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Mekena Reduce Risk Of Premature Births

Image credit: U.S. Air Force.

The drug has already cleared FDA safety tests in random clinical trials involving 463 women aged 16 to 43; of the group taking Mekena, 37% delivered before 37 weeks, compared to 55% of women not on the drug. Another study which evaluated the development of children born to women taking Mekena showed that children aged 2 1/2 to 5 reached similar developmental targets when compared with children born to women not taking the drug.

However, because Mekena will hit the market under the accelerated approval rules, the company must still conduct additional research to further ensure its safety. In accordance to these regulations, the FDA has now launched an International trial to look into the long term outcome of babies born to women taking the drug.

The only other drug that had previously been able to pregnant women with a higher risk of miscarriage, was a drug known as Delalutin. Delalutin was approved for use in 1956 but finally was discontinued in 2000 at the manufacturer’s request.

Talking to WebMD, K-V Pharmaceutical said it was working hard to bring Mekena to the market as soon as possible.


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  1. Bill Hendrick: New Drug Lowers Preterm Birth Risk. WebMD, 02/08/2011.

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