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Progesterone: The Oldest "New" Drug to Nearly Reach the Market

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Poor progesterone -- this white horse in the fight against preterm birth -- has had a rough year.

It wasn't so long ago that my colleagues and I were feeling upbeat: Studies showed that injecting progesterone could prevent preterm birth in women who had previously delivered prematurely, and also that vaginal administration of the same medication could prevent preterm delivery in women who were noted to have a short cervix noted on ultrasound. It was the first proven treatment for early delivery to come along in decades.

The wrinkle in the story was that this new medication was really a very very old drug, but the Food and Drug Administration (FDA) hadn't approved it in a form that could be used to treat preterm delivery. That left doctors like me to prescribe formulations of progesterone from "compounding" pharmacies that mixed the drug themselves.

Smelling profits, two pharmaceutical companies paid big dollars to do the big clinical trials necessary to obtain permission from the FDA to market the drug specifically for preterm-birth prevention. But because progesterone was decades old, everything about the path from research to sales was irregular.

First on the market, KV Pharmaceuticals got approval for the injectable version of the drug -- and promptly pissed off the entire obstetric community and the FDA by charging an exorbitant $1,500 per dose. (The company is still trying to make amends.)

Next, Columbia Laboratories teamed up with the National Institutes of Health to repeat a 2003 study that showed vaginal progesterone would prevent preterm delivery in women with a short cervix on ultrasound. Columbia and the NIH used a FDA-approved formulation of the 8 percent vaginal progesterone gel that Columbia's distribution partner, Watson Pharmaceuticals, was already selling to women with infertility.

Typically, pharmaceutical companies develop drugs, conduct clinical trials, obtain FDA approval and then face with the monumental task of explaining to doctors why their drug is better than the competition.

But in the case of progesterone, the research came first -- in 2003 when landmark papers by Meis and da Fonseca were published -- and since the drug was already available for other indications, most of the marketing was done in the very best way -- by leading obstetricians who had no vested interest in one company or another advocating use of a generic compound that was proven to solve a clinical problem. KV Pharmaceuticals and Columbia Labs were left to play catchup.

I find it surprising that an advisory panel that evaluated the Columbia study recommended on Jan. 20 that the FDA reject the vaginal progesterone, because the drug has a long track record of safe use in pregnancy, and several clinical trials have demonstrated that it works (sounds safe and effective to me). Columbia is now lobbying the FDA (and the public) during the month between the advisory panel's dictum and the FDA's decision, which is scheduled to be released on Feb. 26.

In some respects, the decision doesn't matter very much except to the company's shareholders, who lost two-thirds of their shares' value on the news of the adverse recommendation. (Full disclosure: I own 1,250 shares of Columbia Pharmaceuticals, worth approximately $1,100 as of this writing.) The drug -- 8 percent progesterone gel -- is already FDA-approved for infertility and any doctor can already prescribe it "off label." Additionally, obstetricians are now used to working with compounded progesterone, whether it's a vaginal cream or gel or a solution that can be injected. The recipe is taped to the wall in many an obstetrician's office, where it can be copied onto a prescription pad and sent to the local (or mail-order) compounding pharmacy.

There is a certain comfort that comes from prescribing an approved drug for its FDA-indicated purpose. However, the most exciting news in preterm birth prevention resulted from two studies published in 2003 using compounded progesterone. Since then, the involvement of Pharma and the FDA seems only to have undermined patient care.

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