WASHINGTON (dpa-AFX) - Biopharmaceutical company AbbVie (ABBV) in cooperation with Neurocrine Biosciences, Inc. (NBIX), announced detailed results from a Phase 2b clinical trial evaluating the efficacy and safety of elagolix alone or in combination with add-back therapy (estradiol/norethindrone acetate) compared to placebo.
The data from the 24-week, multicenter, double-blind Phase 2b trial demonstrated that elagolix, with and without add-back therapy, met the primary efficacy endpoint of reduced heavy menstrual bleeding as compared to placebo.
These results were shared for the first time in an oral presentation at the third Congress of the Society of Endometriosis and Uterine Disorders or SEUD in Singapore.
Uterine fibroids are the most common type of abnormal growth in a woman's pelvis and can affect about 20-80 percent of women by age 50. African American women are more likely to experience fibroids and do so at a younger age.
The study's primary endpoint assessed the change in menstrual blood loss from baseline to month six, utilizing the alkaline hematin method, a standard measurement for menstrual blood loss.
The effects of elagolix on heavy menstrual bleeding were rapid as evidenced by a significant reduction in the number of heavy bleeding days based on assessment at month six compared to placebo.
Women treated with elagolix had significant increases in hemoglobin concentration from baseline to month six compared to placebo. Uninterrupted treatment with elagolix was associated with decreased symptom severity and improved quality of life as assessed by the Uterine Fibroid Symptom and QoL or UFS-QoL questionnaire.
The Phase 3 elagolix uterine fibroids program includes two replicate, pivotal, six-month efficacy and safety studies followed by a six-month safety and efficacy extension study. The primary endpoint in Phase 3 studies will assess the reduction in heavy menstrual bleeding compared to placebo as measured by the alkaline hematin method.
Copyright RTT News/dpa-AFX