AbbVie to move ahead with phase III trials of new uterine fibroids treatment

AbbVie has announced plans to begin a phase III programme assessing elagolix as a treatment for uterine fibroids.

Collaborating with Neurocrine Biosciences, the company has completed a phase IIb clinical trial evaluating the safety and efficacy of elagolix alone, or in combination with add-back therapy, compared to placebo.

The trial was conducted in women with heavy menstrual bleeding associated with uterine fibroids, with preliminary results showing that all of the elagolix treatment arms reduced heavy menstrual bleeding as compared to placebo, thus meeting its primary endpoint.

A phase III programme is targeted to begin the first quarter of 2016 and will include two replicate pivotal six-month efficacy and safety trials, followed by a six-month safety and efficacy extension study.

Dr Michael Severino, executive vice-president, research and development and chief scientific officer at AbbVie, said: "The positive results from this trial represent an important milestone in the development of elagolix as a potential new treatment option for women suffering from heavy menstrual bleeding associated with uterine fibroids."

Uterine fibroids are noncancerous muscle tissue tumors of the uterus that can cause longer, more frequent or heavy menstrual bleeding, as well as pain, urination problems or constipation.