Elagolix filed with FDA for management of endometriosis with associated pain.- AbbVie.

AbbVie announced that it has submitted a New Drug Application (NDA) to the U.S. FDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being evaluated for the management of endometriosis with associated pain. In two replicate Phase III clinical studies, elagolix demonstrated superiority compared to placebo in reducing three types of endometriosis-associated pain � daily menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse.

The NDA is supported by data from the largest prospective randomized endometriosis clinical trials conducted to date, which evaluated the safety and efficacy of elagolix in nearly 1,700 women with moderate-to-severe endometriosis-associated pain. The data from two replicate Phase III studies demonstrated that, at month three and month six, both elagolix doses (150 mg once daily and 200 mg twice daily) resulted in a statistically significant higher proportion of responders for menstrual pain (dysmenorrhea) and non-menstrual pelvic pain associated with endometriosis as measured by the Daily Endometriosis Pain Impact scale versus placebo.

Significant improvements compared to placebo were also observed at month three for the 200 mg twice daily dose in scores for painful intercourse (dyspareunia). A reduction in the amount and frequency of rescue pain medication use, including nonsteroidal anti-inflammatory drugs and opioids, compared to placebo was also seen in the higher dose at month three and six. In clinical studies, elagolix treatment decreased endometrial proliferation in a dose-dependent manner after six months of treatment with no adverse endometrial findings. The safety profile of elagolix was consistent with the partial hormone suppression associated with its mechanism of action.