By Mark Dassel, MD
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You may have noticed more commercials on TV about endometriosis. These short spots typically depict a woman at her doctor’s office being asked about painful periods, pain with intercourse or pain between periods ― all common symptoms of endometriosis.
This increased awareness is welcome, especially since it takes women an average of 3 to 11 years from the time their symptoms start until they’re diagnosed with endometriosis. But there’s little doubt that these ads encouraging women to talk to their doctors about endometriosis is timed with the release of a new endometriosis approved by the Food and Drug Administration in July.
The pill, called elagolix and sold under the brand name ORILISSA®, blocks the release of certain hormones in the body, so researchers recognized its potential for being effective against endometriosis. This type of drug has been used for a long time for other endocrine-related conditions, but it’s never been used for prolonged periods of time.
How it stacks up
In 2014, a clinical trial demonstrated that the drug was acceptably safe and effective. Three years later, the results of two more clinical trials showed improvement in both dysmenorrhea (that’s the medical term for menstruation pain) and non-menstrual pelvic pain over six-month’s use for both the 150 mg once-daily and 200 mg twice-daily formulations.
Elagolix is the first medicine in 10 years to be released for the treatment of endometriosis-related pain — but it comes with a steep price tag of approximately $10,000 a year. By working with some insurance companies, the manufacturer of elagolix has taken steps to make it more affordable to patients.
Compared with other endometriosis medications, elagolix has the benefit of being a pill you can take, rather than an injection. And since it works differently in a woman’s body, the treatment avoids an initial flare in symptoms that happens with other available treatment options.
The side effects are similar to other endometriosis treatments that decrease estrogen production, like hot flashes and vaginal dryness. Although some women report only mild to moderate symptoms, others report more severe symptoms. Furthermore, elagolix was shown to raise fatty substances in the blood that increase the risk of heart disease and decrease bone mineral density (increasing osteoporosis risk) with prolonged use (more than six months). This bone mineral density has been shown to improve after going off of other endometriosis medicines, but there is no long-term data yet on elagolix.
Not everyone’s a fan
The release of the elagolix isn’t without controversy, for a few reasons:
- The study used to gain FDA approval was funded by its pharmaceutical manufacturer.
- The study included women who had a diagnosis of endometriosis within the last 10 years, but didn’t mention how severe it was.
- No adequate comparison was made to other medication treatments that have been shown effective for the treatment of endometriosis, such as birth control pills, hormonal injection or norethindrone acetate, a progesterone-only medication.
- The study was relatively short-term, and some women conceived while on the medication, meaning the drug didn’t fully suppress ovulation and menstruation.
It’s also important for women to note that the new medication’s long-term safety and efficacy are not yet understood.
The data thus far
In a study of the medication’s efficacy over a 12-month period at the 200 mg (twice-daily dosage) published in the Journal of Obstetrics and Gynecology:
- 75 to 78% of participants saw an improvement in pain associated with periods.
- 67 to 69% saw an improvement in pain not associated with periods.
- 58 to 60% of participants who reported pain during sex responded favorably.
What does this mean? Many ― but not all – women with endometriosis may not fully benefit from this medication. Traditionally used medications, including oral contraceptives, oral progestins or progestin-containing IUDs, may prove better treatment options in some women. Still others may benefit most from a combination of therapies, which may include surgical intervention, physical therapy or other pain–directed treatment strategies.
Elagolix won’t be the right answer for every endometriosis sufferer. But it’s another treatment option that can help ease chronic pelvic pain in women suffering for this painful disease.
It’s also important to realize that there’s usually not one silver bullet for relief. The pelvic pain that accompanies endometriosis is often multifaceted and can include pelvic floor physical therapy, neuromodulatory medications, muscle/nerve injections or surgical therapies.
It remains to be seen how elagolix will fit into the treatment algorithm, but there is little doubt that the increased focus on endometriosis treatment and education is likely to have a positive effect on the number of women that will seek and receive treatment.