FDA Approves New Drug for Endometriosis Pain

July 24, 2018 -- The FDA has approved elagolix (Orilissa), the first drug developed for the treatment of moderate to severe pain from endometriosis.

The FDA approved elagolix under priority review. It is expected to be available in the U.S. next month.

Elagolix represents a "significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease," Michael Severino, MD, chief scientific officer for AbbVie, the maker of elagolix, says in a news release.

Data from two studies of nearly 1,700 women with moderate to severe endometriosis pain supported the FDA's approval.

In the studies, elagolix reduced the three most common types of endometriosis pain: daily menstrual pelvic pain, nonmenstrual pelvic pain, and pain with sex, AbbVie says.


The company says that elagolix can reduce bone mineral density. Loss of bone mineral density is greater the longer the drug is used and may not be completely reversible after stopping treatment.

The drug should be taken by mouth at roughly the same time each day, with or without food.

"Endometriosis is often characterized by chronic pelvic pain that can impact women's daily activities," Hugh Taylor, MD, study investigator from Yale University School of Medicine in New Haven, CT, says in the 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."