Due to unmet demand and little competition, AbbVie is expecting its drug candidate elagolix to be a success for the treatment of conditions like endometriosis and uterine fibroids. Together with Neurocrine Biosciences of San Diego, California, Abbvie intends to develop and commercialize elagolix and other next-generation gonadotropin-releasing hormone (GnRH) antagonists for women’s and men’s health.
Elagolix is currently being investigated in women with endometriosis and women with uterine fibroids. In February, AbbVie announced positive results from the second of two replicate Phase 3 clinical trials evaluating the effectiveness and safety of elagolix in premenopausal women who suffer pain from endometriosis.
AbbVie reported the study had met co-primary efficacy endpoints, with results showing that after six months of continuous treatment, elagolix at doses of 150 mg once daily and 200 mg twice daily reduced menstrual pain and non-menstrual pelvic pain associated with endometriosis at month three and month six compared to a placebo, as measured by the Daily Assessment of Endometriosis Pain scale.
“Endometriosis affects an estimated 176 million women worldwide. Patients voice their frustration about the need for more treatment options to medically manage endometriosis and its often debilitating pain,” Dr. Michael Severino, MD, AbbVie executive vice president of research and development and chief scientific officer, said in a press release, citing World Endometriosis Research Foundation metrics.
“In an effort to address this need, AbbVie conducted the largest clinical trials in endometriosis to date. We are pleased with the outcomes of the pivotal trials thus far. AbbVie will continue to pursue elagolix as a potential new treatment for the disease’s most common symptoms, including pain related to menstruation and chronic pelvic pain throughout the menstrual cycle,” he said.
Full trial results are to be presented at a medical conference later this year. AbbVie will complete the clinical database in anticipation of submitting an FDA New Drug Application for approval of elagolix for endometriosis in 2017.
According to Neurocrine Bioscienses, elagolix is a novel, orally administered GnRH antagonist. GnRH is a peptide that stimulates secretion of pituitary hormones responsible for sex steroid production and normal reproductive function. Elagolix is believed to exert its therapeutic effect by altering pituitary GnRH suppression levels, resulting in titration of circulating hormone levels. By this action, it is believed elagolix may provide relief from pain associated with conditions such endometriosis and uterine fibroids, without having to also manage bone loss.
Under the terms of the cooperative agreement, AbbVie is responsible for all development, marketing, and commercialization costs and will receive a percentage of sales, and Neurocrine will be entitled to a percentage of worldwide sales of GnRH compounds for 10 years or the duration of related patent rights.
Neurocrine notes that Phase 1 and 2 data for elagolix in women support the potential for the drug’s use in treating other women’s health conditions such as menorrhagia (excessive uterine bleeding) and primary dysmenorrhea that commonly results from underlying endometriosis, uterine fibroids or adenomyosis, and may be treatable with a nonpeptide GnRH antagonist. Potential additional women’s health indications for elagolix include premenstrual dysphoric disease, polycystic ovarian syndrome, breast cancer prevention, and precocious puberty.
You can view clinical trials for elagolix in uterine fibroids information at: