Abortion Drug Serves Secondary Purpose to Cushing Community

After she began presenting with increased anxiety, rapid weight gain, increased blood sugars, and untreatable acne, 40-year old Georgia resident Leslie Edwin was diagnosed with hypercortisolism, also known as Cushing syndrome.

According to an article published in the Chicago Tribune, Edwin underwent numerous surgeries, including one to remove her pituitary gland. When her weight shot up again and her feelings of anxiousness returned, she was prescribed mifepristone, a drug that has been notoriously referred to as “the abortion pill.”

When taken early in a pregnancy, mifepristone can end a pregnancy that is less than 49 days along. Another notable trait of the drug, though, is its ability to control the high blood sugar in patients with Cushing syndrome who have type 2 diabetes and have either failed surgery or are not candidates for it.

Mifepristone has been approved by the U.S. Food and Drug Administration for both indications, people seeking abortions and patients suffering from Cushing syndrome, however, the differences in dosage between the 2 forms of mifepristone are staggering.

The glucocorticoid receptor antagonist helps Cushing syndrome patients by blocking the body’s ability to process cortisol, and induces abortion by progesterone, another of the body’s receptors, which results in the uterine wall breaking down, thus ending pregnancies.

The compound was given the OK nearly 20 years ago as the “abortion drug” with tight restrictions on use. Danco Laboratories won authorization to market it as Mifeprex in the United States as a one-time 200-mg pill that can be purchased approximately $80. In 2012, after years of development and being repurposed, mifepristone was granted approval in the Cushing syndrome indication, and marketed by Corcept Therapeutics as Korlym. A 300-mg pill costs an estimated $550; to see clinical benefit, patients typically take up to 3 pills per day for months or years.

Because the drug as a lot of crossover, or potential uses, developing it costs approximately $300 million and involves long-term toxicology tests to ensure that patients can safely receive high doses over long periods of time.

“We have an expensive drug,” said Joseph Belanoff, chief executive of Corcept Therapeutics in the article. “There’s no getting around that. He added, though, that he believes his company has a “social contract” to tend to patients and vouched that any patient who is prescribed Korlym will receive it, irrespective of insurance coverages or costs. The fact that mifepristone was already notorious for its work with abortions did not help Corcept’s efforts to brand it for Cushing syndrome.

With help from Corcept’s patient assistance program, though, Edwin claims that she has never paid more than $25 a month. "Across the board, it would be very difficult to find any patient that pays the full price," said Edwin, who serves as president of the Cushing's Support and Research Foundation, a nonprofit patient advocacy group.

Still, though, other companies are looking to capitalize on the high pricing for mifepristone by manufacturing their own versions and marketing them for less.

In February, Teva Pharmaceuticals submitted an Abbreviated New Drug Application to the FDA seeking the authorization to manufacture, use, and sell a generic version of mifepristone tablets in the U.S. Less than a month later, Corcept responded by announcing it has filed a lawsuit for infringement.

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