Docs Say the New FDA-Approved Pill to Treat Endometriosis Could Be a Game-Changer
Orilissa is the first new treatment for endometriosis pain in a decade.
Earlier this week, the Food and Drug Administration approved a new drug that might make living with endometriosis easier for the more than 10 percent of women who live with the painful, and sometimes debilitating, condition. (Related: Lena Dunham Had a Full Hysterectomy to Stop Her Endometriosis Pain)
Quick refresher: "Endometriosis is a disease affecting reproductively-aged women where the lining of the uterus grows outside the uterus," says Sanjay Agarwal, M.D., professor of obstetrics, gynecology, and reproductive sciences at UC San Diego Health. "The symptoms can be quite varied but it's most commonly associated with painful periods and pain with intercourse-these symptoms can be horrendous." (Endometriosis can also cause infertility. Earlier this year, Halsey opened up about freezing her eggs at 23 because of her endometriosis.)
Given endometriosis affects 200 million women worldwide, doctors still know shockingly little about what causes the painful lesions. "We're not sure why some women develop it and others don't or why in some women it can be a fairly benign condition and for others it can be a very painful debilitating condition," says Zev Williams, M.D., Ph.D., chief of the Division of Reproductive Endocrinology and Infertility at Columbia University Medical Center.
What doctors do know is that "estrogen tends to make the disease and the symptoms worse," says Dr. Agarwal, which is why endometriosis often causes super-painful periods. It's a vicious cycle, adds Dr. Williams. "The lesions cause inflammation, which causes the body to produce estrogen, which causes more inflammation, and so on," he explains. (Related: Julianne Hough Speaks Out About Her Struggle with Endometriosis)
"One of the goals of treatment is to try to break that cycle either by using medications that lower the inflammation or the presence of estrogen," Dr. Williams says. "In the past, we have done this with things like birth control pills that keep a woman's estrogen levels low or by using medications like Motrin, which are anti-inflammatories."
Another treatment option is stopping the body from producing so much estrogen in the first place-a method that's previously been done via injection, says Dr. Williams. This is exactly how Orilissa, the newly FDA-approved medication, works-except in a daily pill form.
Doctors say the pill, which was approved by the FDA earlier this week and is expected to be available in early August, could be a game-changer for women with moderate to severe endometriosis. "This is a huge thing in the world of women's health," says Dr. Agarwal. "Innovation in the field of endometriosis has been essentially nonexistent for decades, and the treatment options we do have been challenging," he says. While the drug is exciting news, the price for non-insured patients is not. A four-week supply of the drug will cost $845 without insurance, reports the Chicago Tribune.
How does Orilissa treat endometriosis pain?
"Normally the brain causes the ovaries to make estrogen, which stimulates the uterine lining-and endometriosis lesions-to grow," explains Dr. Williams, who consulted with the drug company behind Orilissa as it was being developed. Orilissa gently suppresses endometriosis-triggering estrogen by "blocking the brain from sending the signal to the ovary to produce estrogen," he says.
As estrogen levels taper off, so does the endometriosis pain. In the FDA-evaluated clinical trials of Orilissa, which involved almost 1,700 women with moderate to severe endometriosis pain, the drug significantly reduced three types of endometriosis pain: everyday pain, period pain, and pain during sex.
What are the side effects?
Current treatments for endometriosis often come with side effects like irregular bleeding, acne, weight gain, and depression. "Because this new drug suppresses estrogen gently, it shouldn't have the same magnitude of side effects that other medications can have," says Dr. Agarwal, who was a clinical investigator on the study program.
Most side effects are minor-but because it causes a drop in estrogen, Orilissa can cause menopause-like symptoms like hot flashes, though the experts say there's no evidence that it could kick you into early menopause.
The main risk is that the drug can cause decreased bone density. In fact, the FDA recommends that the drug should only be taken for a maximum of two years, even at the lowest dose. "The concern with decreased bone density is that it can lead to fractures," says Dr. Williams. "This is particularly a concern for women when they're under 35 and are in the years of building up their peak bone density." (Good news: Exercise can help maintain your bone density and reduce osteoporosis.)
So, does that mean Orilissa is only a two-year band-aid at best? Kind of. Once you stop the drug, the experts say the pain will likely start to slowly come back. But even two pain-free years are important. "The goal of hormonal management is to try to delay the growth of the endometriosis lesions to relieve the symptoms and either prevent the need for surgery or delay when the surgery would be needed," says Dr. Williams.
After you've maxed out your time taking the drug, most docs would recommend going back to a treatment like birth control to help stave off that regrowth, Dr. Williams says.
The bottom line?
Orilissa is not a magic bullet, nor is it a cure for endometriosis (unfortunately, there still isn't one). But the newly approved pill does represent a massive step forward in treatment, especially for women dealing with severe pain, Dr. Agarwal says. "This is a very exciting time for women that have endometriosis."