Elagolix NDA Submitted for Treating Endometriosis-Associated Pain
AbbVie announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for elagolix, an investigational drug for the management of endometriosis with associated pain.
Elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, was evaluated in two Phase 3 clinical studies in about 1,700 women with moderate-to-severe endometriosis-associated pain. The data showed at Months 3 and 6, elagolix 150mg once daily and elagolix 200mg twice daily led to a statistically higher proportion of responders for dysmenorrhea and non-menstrual pelvic pain associated with endometriosis as measured by the Daily Endometriosis Pain Impact scale vs. placebo.
Also, there were significant improvements seen at Month 3 with elagolix 200mg twice daily in scores for dyspareunia vs. placebo. The frequency and amount of rescue pain medications (eg, NSAIDs, opioids) used were also reduced with the higher dose at Months 3 and 6 vs. placebo.
Treatment with elagolix also reduced endometrial proliferation in a dose-dependent manner after 6 months with no adverse endometrial findings. The safety characteristics of elagolix proved consistent with the partial hormone suppression associated with its mechanism of action; the data were consistent across previous studies and Phase 3 trials.
Elagolix works through reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to decreased ovarian production of estradiol and progesterone. Elagolix is being studied in other sex hormone-mediated diseases such as uterine fibroids.
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