In 2 extension studies, no new safety concerns were identified for the 12-month treatment period.
AbbVie announced positive data from 2 replicate phase 3 extension trials, studying the long-term efficacy and safety of elagolix which is being evaluated for the management of endometriosis with associated pain.
In the extension studies, Elaris EMIII and Elaris EMIV, elagolix demonstrated sustained reduction in the average monthly menstrual pelvic pain and non-menstrual pelvic pain in women throughout the 12-month treatment period. The objective of the studies was to evaluate the long-term safety and efficacy of elagolix for the management of endometriosis with associated pain.
"Currently, physicians have limited options for the long-term medical management of endometriosis and are in need of additional treatment options to help manage this chronic and painful disease,” Hugh S. Taylor, MD, study investigator and Chair of the Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, told MD Magazine. “Physicians may consider alternative means of treatment that are not specifically designed to treat endometriosis or women living with endometriosis may endure repetitive and costly surgical procedures. If approved by the FDA, elagolix has the potential to be an important oral treatment option for women suffering from the most prevalent symptoms of endometriosis.”
Elaris EMIII and Elaris EMIV are 2 extension studies of the 6 month pivotal phase 3 studies Elaris EM-I and Elaris EM-II, which evaluated an additional 6 months of treatment with 2 elagolix doses, 150 mg once daily and 200 mg twice daily. Study participants were women aged 18—49 with surgically diagnosed endometriosis and moderate to severe endometriosis-associated pain at baseline during the trials.
The efficacy endpoints of the pivotal studies were the proportion of responders based on the average monthly dysmenorrhea and non-menstrual pelvic pain scores measured by the Daily Assessment of Endometriosis Pain scale.
The reductions of dysmenorrhea and non-menstrual pelvic pain following 6 months of elagolix treatment were maintained throughout the 6 additional months of treatment, across both extension studies for both 150 mg once daily, and 200 mg twice daily doses.
More than 50% of women responded for dysmenorrhea and non-menstrual pelvic pain at both doses. The responder rate for dyspareunia after 12 months was higher with the 200 mg twice daily dose than with the 150 mg once daily dose, which reflects a dose-dependent effect and is similar to data reported in pivotal studies.
Safety assessments in the extension studies included evaluation of adverse effects, along with clinical laboratory tests and changes in bone mineral density. The proportion of women with new incidences of hot flush ranged between 4—8% across both studies and doses. Tolerability and safety were consistent with the effects of reduced estradiol levels. No new safety concerns were identified.
The US Food and Drug Administration (FDA) granted priority review for the AbbVie’s New Drug Application for endometriosis in Q4 2017 Elagolix is currently being investigated in diseases mediated by ovarian sex hormones like uterine fibroids.
To date, it’s been studied in more than 40 clinical trials with more than 3,000 subjects. Phase 3 trials of elagolix for the management of uterine fibroids are ongoing. A press release has been made available.