FDA approves drug to control endometriosis pain

By Allen Cone

July 25 (UPI) -- The U.S. Food & Drug Administration has approved a new treatment for pain caused by endometriosis, a common gynecologic disorder.

Abbvie, a research-oriented global biopharmaceutical company based in suburban Chicago, announced Tuesday the FDA has approved elagolix as the brand name Orilissa.


Endometriosis affects an estimated one in 10 women of reproductive age, according to the U.S. Department of Health and Human Services. About 30 percent to 40 percent of women with the condition are infertile.

Symptoms include painful cramps or periods, heavy periods, chronic pelvis and intestinal pain and pain during or after sex.

"Endometriosis is often characterized by chronic pelvic pain that can impact women's daily activities," Dr. Hugh S. Taylor, study investigator and chairman of the Department of Obstetrics, Gynecology and Reproductive Sciences at Yale School of Medicine, said in a company press release. "Women with endometriosis may undergo multiple medical treatments and surgical procedures seeking pain relief and this approval gives physicians another option for treatment based on a woman's specific type and severity of endometriosis pain."

AbbVie, which spun off of Abbott Laboratories in 2013, said elagolix is the first and only oral gonadotropin-releasing hormone antagonist specifically developed for women with moderate to severe endometriosis pain. The drug, which is the first FDA-approved oral treatment to treat the condition's pain in 10 years, is expected to be available in U.S. retail pharmacies early next month.


The drug will cost about $850 per month, according to Biopharma Dive, a website covering the biopharmacy industry.

"Orilissa represents a significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease," Dr. Michael Severino, the chief scientific officer at AbbVie, said. "The approval of Orilissa demonstrates AbbVie's continued commitment to address serious diseases and unmet needs."

Endometriosis-associated pain is currently managed with medicines such as oral contraceptives, nonsteroidal anti-inflammatory drugs, opioids and hormonal therapies.

In more severe cases, laparotomy, laparoscopy or hysterectomy surgeries are often pursued.

Two phase 3 studies were conducted among nearly 1,700 women with moderate to severe endometriosis pain. In the trials, the drug significantly reduced daily menstrual pelvic pain, non-menstrual pelvic pain and pain with sex.

Orilissa is recommended for up to 24 months for the 150 mg , once-daily dose and up to six months for the 200 mg, twice-daily dose. The company noted a decrease in bone mineral density using the medication.

The most common side effects are hot flashes or night sweats, headache, nausea, difficulty sleeping, absence of periods, anxiety, joint pain, depression and mood changes, according to the trials.

People who are pregnant, have osteoporosis, severe liver disease, or take medicines known as strong OATP1B1 inhibitors such as cyclosporine or gemfibrozil are urged not to take the drug.


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