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# AbbVie Plans NDA for Endometriosis Drug
- URL: https://www.fdaweb.com/abbvie-plans-nda-for-endometriosis-drug/
- Published: 2016-02-11T12:00:00.000Z
- Updated: 2026-09-15T02:35:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134741

> AbbVie says it will file an NDA for Elagolix next year after announcing positive top-line results from the second of two replicate pivotal Phase 3 clinical trials evaluating the drug in premenopausal women who suffer pain from endometriosis. Trial results show that after six months of continuous treatment, both elagolix doses (150 mg once daily and 200 mg twice daily) met the study’s co-primary endpoints, the company says, adding that “Elagolix reduced scores of menstrual pain and non-menstrual pelvic pain associated with endometriosis compared to placebo.  
>  
> Abbvie says the drug’s safety profile in this study was consistent with observations from prior studies. Among the most common treatment-emergent adverse events were hot flush, headache, and nausea. “As anticipated by the mechanism of action,” it says, some events were dose-dependent, and overrall discontinuation rates were similar across treatment groups.  
>  
> Elagolix is an orally administered gonadotropin-releasing hormone (GnRH) antagonist that is currently being investigated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis. To date, it has been studied in over 40 clinical trials totaling more than 3,000 subjects. Phase 3 trials for managing uterine fibroids are also ongoing.