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Positive Results Reported for Endometriosis Drug Elagolix

Treatment reduces dysmenorrhea and pelvic pain in phase III study

Positive results have been reported from the second of two replicate pivotal phase III trials evaluating the efficacy and safety of elagolix (AbbVie/Neurocrine Biosciences) in premenopausal women with pain from endometriosis. After six months of continuous treatment, both doses of elagolix (150 mg once daily [QD] and 200 mg twice daily [BID]) met the study’s co-primary endpoints. Elagolix reduced the scores for menstrual pain (dysmenorrhea) and nonmenstrual pelvic pain associated with endometriosis at three and six months, as measured by the Daily Assessment of Endometriosis Pain scale.

Elagolix is an orally administered gonadotropin-releasing hormone (GnRH) antagonist that is being investigated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis.

The new study was a 6-month, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of elagolix in 815 women (18 to 49 years of age) with moderate-to-severe endometriosis-associated pain.

At month 3, dysmenorrhea was improved in 23% (80/353) of the placebo group, in 43% (96/221) of the elagolix 150 mg QD group (P < 0.001 vs. placebo), and in 72% (163/225) of the elagolix 200 mg BID group (P < 0.001 vs. placebo). Similarly, at month 3, nonmenstrual pelvic pain improved in 37% (129/353) of the placebo group, in 50% (110/221) of the elagolix 150 mg QD group (P = 0.003 vs. placebo), and in 58% (130/225) of the elagolix 200 mg BID group (P < 0.001 vs. placebo).

At month 6, dysmenorrhea showed improvement in 25% (90/355) of the placebo group, in 46% (102/221) of the elagolix 150 mg QD group (P < 0.001 vs. placebo), and in 77% (173/225) of the elagolix 200 mg BID group (P < 0.001 vs. placebo). Similarly, at month 6, nonmenstrual pelvic pain improved in 41% (144/355) of the placebo group, in 52% (114/221) of the elagolix 150 mg QD group (P = 0.010 vs. placebo), and in 62% (140/225) of the elagolix 200 mg BID group (P < 0.001 vs. placebo).

The most common treatment-emergent adverse events (TEAEs) included hot flush, headache, and nausea. Overall discontinuation rates were similar across treatment groups (25%, 21%, and 20% for placebo, elagolix 150 mg QD, and elagolix 200 mg BID, respectively). Discontinuation rate specifically due to TEAEs were 6%, 4%, and 10%, respectively.

A new drug application for elagolix in endometriosis is expected in 2017.

Source: AbbVie; February 10, 2016.

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