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Elagolix reduces endometriosis-associated pain compared to placebo


Results from the second of two replicate pivotal phase 3 clinical trials evaluating the efficacy and safety of Elagolix in premenopausal women who suffer pain from endometriosis were presented.
Trial results have shown that after six months of continuous treatment, both doses of Elagolix ( 150 mg once daily and 200 mg twice daily ) met the study's co-primary endpoints.
Elagolix has reduced scores of menstrual pain ( dysmenorrhea ) and non-menstrual pelvic pain associated with endometriosis, at month three and month six, as measured by the Daily Assessment of Endometriosis Pain scale.
Responder rates for the co-primary endpoints from this second phase 3 pivotal study are consistent with results from the first phase 3 pivotal study.

Elagolix is an orally administered gonadotropin-releasing hormone ( GnRH ) antagonist.

The phase 3 trial, M12-671, employed the same design as the first phase 3 pivotal trial but was multinational and included 815 women with moderate-to-severe endometriosis-associated pain across 226 sites in 13 countries ( US and 12 Ex-US countries ).

At month 3, dysmenorrhea was improved in 23% of the placebo group, in 43% of the Elagolix 150 mg QD group ( P less than 0.001 vs. placebo ), and in 72% of the Elagolix 200 mg BID group ( P less than 0.001 vs placebo ).
Similarly, at month 3, nonmenstrual pelvic pain improved in 37% of the placebo group, in 50% of the Elagolix 150 mg QD group ( P = 0.003 vs placebo ), and in 58% of the Elagolix 200 mg BID group ( P less than 0.001 vs placebo ).

At month 6, dysmenorrhea showed improvement in 25% of the placebo group, in 46% of the Elagolix 150 mg QD group ( P less than 0.001 vs placebo ), and in 77% of the Elagolix 200 mg BID group ( P less than 0.001 vs placebo ).
Similarly, at month 6, nonmenstrual pelvic pain improved in 41% of the placebo group, in 52% of the Elagolix 150 mg QD group ( P = 0.010 vs placebo ), and in 62% of the Elagolix 200 mg BID group ( P less than 0.001 vs placebo ).

The safety profile of Elagolix in this study was consistent with observations from the first phase 3 pivotal study and prior Elagolix studies.
Among the most common treatment-emergent adverse events ( TEAEs ) were hot flush, headache, and nausea. As anticipated by the mechanism of action, some adverse effects, such as hot flush, other hypoestrogenic TEAEs and changes in bone mineral density ( BMD ) were dose-dependent.

Overall discontinuation rates were similar across treatment groups ( 25.3%, 21.2%, and 19.7% for placebo, 150 mg once daily and 200 mg twice daily, respectively ); discontinuations specifically due to TEAEs were 6.1%, 4.4%, and 10.0% for placebo, 150 mg once daily and 200 mg twice daily, respectively.

Endometriosis occurs when the cells that normally line the uterus begin to grow outside of the uterus. These growths are called lesions and can occur on the ovaries, the fallopian tubes, or other areas near the uterus.
There is no cure for endometriosis, which is currently managed with oral contraceptives, NSAIDs, opioids, and GnRH agonists.
When these medical treatments fail, surgical interventions ( e.g., laparotomy or laparoscopy ) are often pursued, and again, are not curative.
Endometriosis can also be associated with infertility. ( Xagena )

Source: AbbVie, 2016

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