- AbbVie (NYSE:ABBV) is up 2% premarket, albeit on only 201 shares, following its announcement of positive results from a 567-subject Phase 2b clinical trial assessing elagolix, alone or with add-back therapy (estradiol/norethindrone acetate), in women with heavy menstrual bleeding associated with uterine fibroids. The data were presented at the 3rd Congress of the Society of Endometriosis and Uterine Disorders in Singapore.
- The study met its primary endpoint of demonstrating a statistically significant reduction in heavy menstrual bleeding compared to placebo (p<0.001) as determined by the change from baseline to month 6 in menstrual blood loss using a standard measure called the alkaline hematin method.
- The most common adverse events were hot flush, headache and insomnia. Add-back therapy reduced the incidence of hot flushes in a dose-dependent manner. Reduction in bone mineral density associated with elagolix alone was mitigated with the addition of add-back therapy, with only slight effects on efficacy.
- Elagolix, now in Phase 3 development, is an orally administered inhibitor of gonadotropin-releasing hormone receptors in the pituitary gland. It is being investigated in disorders mediated by sex hormones, such as uterine fibroids and endometriosis. AbbVie licensed it from Neurocrine Biosciences (NASDAQ:NBIX) in 2010.
- Previously: AbbVie's Elagolix successful in two late-stage endometriosis studies; U.S. marketing application planned in 2017 (Oct. 19, 2016)
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