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Orilissa Approved for Pain Management of Endometriosis

AbbVie news release; 2018 July 24

The US Food and Drug Administration (FDA) has approved Orilissa (elagolix) for the management of moderate to severe pain associated with endometriosis. The treatment is available in 2 oral dosages (150 mg and 200 mg twice daily) from AbbVie, North Chicago, IL.

Indication: Orilissa is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis.

Dosage and administration: The recommended duration is up to 24 months for the 150 mg daily dose and up to 6 months for the 200 mg twice daily dose.

Safety & efficacy: Clinical trial data from 2 replicate studies that evaluated nearly 1,700 women with moderate to severe endometriosis pain demonstrated Orilissa significantly reduced the 3 most common type of endometriosis pain: daily menstrual pelvic pain, non-menstrual pelvic pain, and pain with sex.

Adverse reactions: Most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions, and mood changes.

Citation:

AbbVie receives U.S. FDA approval or ORLISSA (elagolix) for the management of moderate to severe pain associated with endometriosis. [news release]. North Chicago, IL: AbbVie; July 24, 2018. https://news.abbvie.com/news/abbvie-receives-us-fda-approval-orilissa-el.... Accessed July 24, 2018.