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) agonist medication, for the treatment of endometriosis. To date, other GN-RH agonists 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 will likely be available in US pharmacies starting in August 2018, and is approved for moderate to severe endometriosis.2

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

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 Like any medication, Orilissa may cause side effects. For example, Orilissa may lead to bone mineral density loss.2 Orilissa is not recommended for women who are pregnant, have osteoporosis, have severe liver disease, or are taking certain medications.2

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