AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced the initiation of the first of two planned Phase 3 clinical studies evaluating the safety and efficacy of Elagolix alone or in combination with add-back therapy compared to placebo. These studies are designed to assess the change in menstrual blood loss utilizing the alkaline hematin method, comparing baseline to month six of treatment. Additional secondary efficacy endpoints are being evaluated; including assessing changes in fibroid volume, monthly blood loss and hemoglobin levels. Bone mineral density will also be assessed.
"There are limited, non-surgical treatment options for women suffering from heavy menstrual bleeding associated with uterine fibroids. AbbVie is eager to further explore Elagolix's potential to address this unmet need," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.
The Elagolix Phase 3 uterine fibroid clinical development program is part of AbbVie's pipeline and includes two replicate, randomized, parallel, double-blind, placebo-controlled clinical trials. Each trial is expected to enroll approximately 400 subjects for an initial six-month placebo-controlled dosing period, after which, subjects who are eligible will have an option to continue for an additional six-month dosing period in a safety and efficacy extension study. AbbVie will make a $15MM milestone payment to Neurocrine Biosciences upon enrollment of the first patient.
Uterine fibroids (also called leiomyomas or myomas) are noncancerous muscle tissue tumors of the uterus. Fibroids are most common in women aged 30-40 years but can occur at any age. They can range in size from nearly undetectable to bulky masses that can distort the uterus. Fibroids can be asymptomatic but in some women cause symptoms such as: longer, more frequent, or heavy menstrual bleeding; menstrual pain; vaginal bleeding at time other than menstruation; pain in the abdomen or lower back; pain during sex; difficulty urinating; frequent urination; constipation or rectal pain.