The first drug established for the treatment of moderate to severe pain from endometriosis named elagolix (Orilissa), has been approved by the FDA.
The FDA approved elagolix under priority review. It is expected to be available next month in the U.S.
In a news release, the maker of elagolix, Michael Severino, MD, chief scientific officer for AbbVie says “Elagolix represents a significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease.”
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Data from two studies of nearly 1,700 women with moderate to severe endometriosis pain maintained the FDA’s approval.
Abbvie says elagolix reduced the three most common types of endometriosis pain: daily menstrual pelvic pain, nonmenstrual pelvic pain, and pain with sex, for the study.
According to the company, elagolix can reduce bone mineral density. Loss of bone mineral density is greater the longer the drug is used and may not be totally reversible after discontinuing treatment.
The drug should be taken orally or by mouth at roughly the same time each day, with or without food.
Endometriosis is often characterized by chronic pelvic pain that can affects daily activities of women.
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Hugh Taylor, MD, study investigator from Yale University School of Medicine in New Haven, CT, says women with endometriosis may experience multiple medical treatments and surgical procedures seeking pain relief, and “this approval gives doctors another option for treatment based on a woman’s specific type and severity of endometriosis pain.”