- A second Phase 3 clinical trial assessing AbbVie's (NYSE:ABBV) Elagolix in postmenopausal women with pain caused by endometriosis successfully met its co-primary endpoints. Results showed that both doses of Elagolix (150 mg once a day and 200 mg twice a day) reduced scores of menstrual pain and non-menstrual pelvic pain at month three and six compared to placebo. All results were statistically significant. Responder rates were consistent with those observed in the first Phase 3 study.
- The safety profile was also consistent with the first Phase 3. The most common treatment-emergent adverse events (TEAEs) were hot flush, headache and nausea. Overall discontinuation rates for placebo, 150 mg and 200 mg were 25.3%, 21.2% and 19.7%, respectively. Discontinuations specifically due to TEAEs were 6.1%, 4.4% and 10.0%, respectively.
- The results from both studies will be presented at a future medical conference. The company plans to file a New Drug Application (NDA) with the FDA for endometriosis in 2017.
- Elagolix 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 (NBIX) in June 2010.
- Previously: Neurocrine Bio up on positive Phase 3 results (Jan. 8, 2015)