Orilissa Approved to Treat Endometriosis Pain
July 24, 2018 – The U.S. FDA has approved Orilissa™ (elagolix) tablets, manufactured by AbbVie and Neurocrine Biosciences, to relieve moderate to severe endometriosis pain. Orilissa is the first new endometriosis treatment to receive FDA approval in more than ten years.
Approximately 1 in 10 women in the United States have endometriosis, though diagnosis is often delayed due to a lack of education amongst both patients and physicians regarding the disease and its symptoms. Any woman of reproductive age, including young girls who have only recently begun menstruating, can develop the condition. Endometriosis occurs when tissue similar to the uterine lining forms outside of the uterus. Typically, this tissue is found in the pelvic region and on the bladder and bowel, but sometimes forms in the diaphragm and on the patient’s lungs.
Endometriosis can cause chronic inflammation and pelvic pain, as well as heavy menstrual bleeding, fatigue, and infertility. It can also cause painful periods, ovulation, and intercourse. Symptoms may last into and following menopause as a result of scarring and adhesions caused by the disease.
In clinical studies, women who received Orilissa reported a reduction in endometriosis pain compared to baseline. Women treated with Orilissa were also more likely to report a reduction in pain compared to women who received a placebo. The studies focused on three of the most common types of endometriosis pain: daily menstrual pelvic pain, non-menstrual pelvic pain, and pain with intercourse.
Recommended dosing with Orilissa is 150mg twice daily for up to 24 months, or 200mg twice daily for up to six months. Women with moderate hepatic impairment should take no more than 150mg for up to six months. The use of Orilissa is associated with dose-dependent decrease in bone mineral density (BMD), which can increase over time and may not be reversible.
Orilissa has already been launched at a list price of $10,100 per year.