Endometriosis makes women miserable. In this condition, tissue that normally lines the uterus (endometrial tissue) escapes and proliferates elsewhere in the pelvic cavity. This problem affects as many as one woman out of every ten. Frequently, it leads to extremely painful and copious menstrual periods. Women with endometriosis may also suffer pain at other times, including during sexual activity. In addition, women with significant endometriosis may have trouble conceiving when they wish to have babies.
New Treatment for Endometriosis Pain:
The Food and Drug Administration just approved a new drug for treating moderate to severe endometriosis pain. Elagolix will be sold under the brand name ORILISSA. It works by blocking receptors for gonadotropin releasing hormone, or GnRh. This in turn lowers levels of the female hormones estradiol and progesterone.
According to studies published in the New England Journal of Medicine, elagolix relieved pelvic pain better than placebo. The researchers noted, however, that lower levels of estrogen were associated with reduced bone mineral density, more hot flashes, and increases in LDL cholesterol. The official prescribing information also warns about depression, mood changes and headaches as well as liver enzyme elevations.
Because of concern about side effects, especially lower bone mineral density, women will be able to take the lower dose (150 mg once a day) for up to two years, not longer. They will be limited to six months’ use of the higher dose (200 mg twice a day). Otherwise, this treatment for endometriosis pain could result in painful bone fractures from drug-induced osteoporosis later on.
Side Effect for the Wallet:
The oral medication is expected to cost as much as $10,000 per year. Because the drug is not a cure, women will need to take it indefinitely. Orilissa approval has bolstered the stock price of AbbVie, its manufacturer, but it is not clear how many insurance plans will pay for this medication.