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Endometriosis Treatment Shows Promise in Late-Stage Trial
Positive results have been reported from the first of two ongoing phase III clinical trials designed to evaluate the efficacy and safety of elagolix in premenopausal women with endometriosis.
Elagolix inhibits gonadatropin-releasing hormone (GnRH) receptors in the pituitary gland and ultimately reduces circulating sex hormone levels, according to the drug’s developers (AbbVie/Neurocrine Biosciences).
The new trial is a 24-week, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of elagolix in 872 women (18 to 49 years of age) with moderate-to-severe endometriosis-associated pain. The trial is being conducted at approximately 160 sites in the U.S., Puerto Rico, and Canada.
Results from a group-level analysis showed that after 6 months of treatment, both doses of elagolix (150 mg once daily and 200 mg twice daily) met the co-primary endpoints of reducing scores of non-menstrual pelvic pain (NMPP) and menstrual pain (or dysmenorrhea) associated with endometriosis at 3 months and 6 months compared with placebo (P < 0.001), as measured by the Daily Assessment of Endometriosis Pain scale.
The most common adverse events (AEs) associated with elagolix included hot flush, headache, nausea, and fatigue. While most AEs were similar across treatment groups, some, such as hot flush and loss of bone mineral density (BMD), were dose-dependent. Discontinuation rates due to AEs were 5.9%, 6.4%, and 9.7% for placebo, elagolix 150 mg once daily, and elagolix 200 mg twice daily, respectively.
Patients in this trial will continue in either post-treatment follow-up or a blinded 6-month extension study.
A phase IIb trial of elagolix for the treatment of uterine fibroids is ongoing.
Endometriosis is associated with a multitude of symptoms, some of the most common of which include pain related to menstruation as well as chronic pelvic pain throughout the menstrual cycle, and is a leading cause of infertility. The World Endometriosis Research Foundation estimates that endometriosis affects one in ten women during their reproductive years, representing approximately 176 million women worldwide.
Source: AbbVie; January 8, 2015.