FDA Approves Orilissa (elagolix) for Moderate to Severe Endometriosis Pain

Earlier this month, the US Food and Drug Administration approved Orilissa (egagolix), an oral gonadotropin-releasing hormone receptor (Gn-RH) antagonist medication, for the treatment of endometriosis. To date, other GN-RH agonists and antagonists used to treat endometriosis include Lupron, Lupaneta Pack, Zoladex, and Synarel. According to a press release from the manufacturing companies (AbbVie and Neurocrine Biosciences), Orilissa is the first FDA-approved oral treatment specifically developed for women with endometriosis pain in over 10 years.1,2 The drug is approved for moderate to severe endometriosis.2

What did the clinical trials show?

Leading up to the approval of Orilissa, the manufactures conducted clinical trials of almost 1,700 women with endometriosis, the largest endometriosis Phase 3 study to date.1,2 In clinical trials, the drug was shown to reduce daily menstrual pelvic pain, non-menstrual pelvic pain, and pain with sex.2

How does Orilissa work?

Orilissa works by binding to pituitary GnRH receptors, inhibiting GnRH signals, thus reducing pituitary secretion of both follicle-stimulating hormone (FSH) and luteinizing hormone (LH). This results in a decrease in the production of ovarian hormones estradiol and progesterone.

Orilissa is available in two doses: 150 mg taken once daily and 200 mg taken twice daily. The recommended duration for Orilissa is up to 24 months for the once daily dose, and up to six months for the twice daily dose.2

What are the side effects?

Some people may experience side effects from Orilissa including: hot flashes, night sweats, headache, nausea, difficulty sleeping, missing periods, anxiety, joint pain, loss of bone mineral density, depression, and mood changes.

Who can take Orilissa?

Orilissa should not be taken if you are pregnant, have osteoporosis, or have severe liver disease.2 Your doctor will know what dosage forms and strengths are right for you by considering your full medical history and the presence of other conditions. Your doctor will also consider if you taking any medications, vitamins, or supplements; especially strong OATP1B1 inhibitors, such as the drugs cyclosporine or gemfibrozil.3,4

Click here for full prescribing and safety information.

View References
  1. Barber J. US approves AbbVie, Neurocrine Biosciences' Orilissa for pain associated with endometriosis. FirstWorld Pharma. http://www.firstwordpharma.com/node/1580636#axzz5MGcALSAD. Published July 24, 2018. Accessed July 26, 2018.
  2. AbbVie Receives U.S. FDA Approval of ORILISSA™ (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis. AbbVie Pressroom. https://news.abbvie.com/news/abbvie-receives-us-fda-approval-orilissa-elagolix-for-management-moderate-to-severe-pain-associated-with-endometriosis.htm. Published July 24, 2018. Accessed July 26, 2018.
  3. Prescribing Information. RXAbbVie. https://www.rxabbvie.com/pdf/orilissa_pi.pdf. Accessed March 7, 2019.
  4. Orilissa. Orilissa. https://www.orilissa.com/. Accessed March 7, 2019.

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