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12:00 AM
Sep 15, 2008
 |  BioCentury  |  Product Development

The elagolix fix

All marketed endometriosis drugs have problematic side effects, especially when taken long term. Doctors would like to have a drug that can be taken safely over a long period of time, and Neurocrine Biosciences Inc. thinks its elagolix will fill the bill. The company recently released top-line Phase II data that it believes showed that once-daily oral elagolix can reach target estradiol levels without the side effects of marketed drugs, which include bone loss, weight gain and bleeding.

"There is a huge need in treating endometriosis pain. The goal is to have a long-term drug that wouldn't cause bad side effects like bone loss or weight gain," said Robert Schenken, chair of the department of obstetrics and gynecology at the University of Texas Health Science Center at San Antonio and former president of the American Society for Reproductive Medicine(ASRM).

David Adamson, director of Advanced Reproductive Care Inc.and president of ASRM, agreed. "No data exist so far to demonstrate that any class of drug is superior to another for pain relief [in endometriosis]. Side effects matter. The choice of what drug to take is based on cost and side effects," he said.

Neither has been involved in clinical trials for endometriosis, a condition in which tissue similar to endometrium in the uterus is found elsewhere, primarily in pelvic areas.

Although the cause of endometriosis is unknown, the main pharmaceutical strategy is to treat pain caused by the disease by lowering estrogens, particularly estradiol, which promote growth of endometrial tissue.

Drugs used to treat the condition include GnRH/LHRH receptor agonists like Lupron Depot from Abbott Laboratories and Synarel naferelin from Pfizer Inc.; progestins like Pfizer's depo-subQ provera 104 (DMPA); off-label oral contraceptives consisting of progestins and estrogens; and danazol, a generic synthetic androgen.

While progestins and oral contraceptives are inexpensive, they can have severe side effects including irregular vaginal bleeding, depression, acne, weight gain and bloating. Danazol can cause weight gain,...

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