The FDA Just Approved Orilissa To Reduce Endometriosis Pain Caused By Periods & Sex
Great news for everyone who's been living with endometriosis: The Food and Drug Administration just approved the first new drug in a decade intended to treat the intense pain associated with endometriosis, according to the Associated Press. Orilissa can be taken either once or twice daily for a set period of time, and reportedly showed particular promise in reducing symptoms during sex and menstruation.
Endometriosis, for reference, is a disorder affecting an estimated 11 percent of U.S. women. "[It's] a chronic condition that results when the tissue that lines the uterus also grows outside the uterus," Beth Battaglino, RN and CEO of HealthyWomen, tells Bustle. "This tissue builds up and forms adhesions that can attach to the bladder, they can attach to the bowel, vagina, and other places within the reproductive tract." Stray endometrium accumulates with every menstrual cycle, but if it's outside the uterus, the body can't expel it every month.
"It can cause severe pain ... and symptoms such as heavy or irregular bleeding," Battaglino says. "It can cause cramping, stomach problems including constipation, and painful intercourse. And it can also impact a [person's] quality of life, it can interfere with [their] relationship and it can also affect [their] fertility."
In trials, according to the AP, Orilissa "significantly reduced" period pain in 45 person of participants given a low dose — presumably, the FDA' s recommended 150 mg once daily — and in 75 percent of people given the high dose (or, 200 mg twice daily). For reference, only 20 percent of subjects given placebos reported decreased discomfort.
Battaglino says the drug has the staff at HealthyWomen "clapping our hands and smiling" especially because so few targeted treatments for endometriosis existed before now. She nods to Lupron, an injectable drug used to help patients manage their symptoms. But a shot requires regular visits to a doctor's office, a costly proposition, both in terms of time and dollars — especially for people without insurance. Otherwise, people living with endometriosis typically had pain medications, (expensive) hormone therapy, or surgery to consider.
And true, Orilissa comes with a high price tag — $845 every four weeks if you don't have insurance — but Battaglino expects AbbVie, the company that makes it, will come out with measures that make the drug more affordable for the common consumer. These are early days, and the existence of an endometriosis drug is well worth celebration.
Because yes: If you cannot uncrimp yourself from a crampy ball of gouging ache, it becomes difficult to do basic things like show up to work and school. When you consider that pain from endometriosis drove actress Lena Dunham to have her whole uterus surgically removed, and when you consider the relatively high number of people who've received endometriosis diagnoses, it begins to feel a little odd that we're only getting an Orilissa now. Overdue, to say the least.
Part of the problem, Battaglino says, has classically been that endometriosis can be difficult to spot: It's hard, after all, to pinpoint exactly what qualifies as extreme menstrual pain when you only have your own period experience to go on. And then, people only recently started talking about this — the previous lack of awareness may mean that health care providers and patients alike overlooked endometriosis as a possible culprit behind staggering pelvic pain. Many medical professionals may be unaware of the symptoms, she notes, and many patients may not connect the dots.
"You can just dismiss it as your monthly period pain," Battaglino says, "so usually women go from six to 10 years before an accurate diagnosis of endometriosis actually takes place."
Battaglino recommends tracking your symptoms and cycle, scoring period pain on a scale from 1 to 10 — that way, you're more likely to notice when cramps feel more aggressive than usual, and you can easily communicate the change to your doctor. (Whom you should definitely call if ever pelvic pain begins to detract from your quality of life.)
"Know your own symptoms and don’t be embarrassed," Battaglino says. "Have the conversation with your health care professional, because it’s an exciting time now — we have access to a new drug that can help women who are living with endometriosis."