FDA Approves New Option for Endometriosis Pain

The FDA has approved Orilissa (elagolix), the first oral gonadotropin-releasing hormone antagonist specifically developed for women with moderate to severe endometriosis pain.

The approval is based upon data from 2 replicate studies in the largest endometriosis Phase 3 study program ever conducted, which included data from nearly 1700 women with moderate to severe endometriosis pain. Overall, those women taking Orilissa had significantly reduced rates of daily menstrual pelvic pain, non-menstrual pelvic pain, and pain with sex. Further, a larger proportion of women treated with Orilissa 150 mg once daily and 200 mg twice daily responded in a dose-dependent manner for daily menstrual pain and non-menstrual pelvic pain compared with those taking placebo at month 3.

The recommended duration of use for Orilissa is up to 24 months for 150 mg once daily and up to 6 months for 200 mg twice daily. Treatment with Orilissa may cause decreases in bone mineral density.

Possible serious adverse effects include suicidal thoughts and worsening mood, as well as abnormal liver tests. Common side effects include hot flashes, night sweats, headache, nausea, difficulty sleeping, absence of periods, anxiety, joint pain, depression, and mood changes.

—Michael Potts


AbbVie Receives U.S. FDA approval of Orilissa™ (elagolix) for the management of moderate to severe pain associated with endometriosis [press release]. North Chicago, Illinois. July 24, 2018.