AbbVie Inc.'s second phase 3 study of elagolix met its main goal of reducing heavy menstrual bleeding in women with uterine fibroids.
Uterine fibroids, also known as leiomyomas or myomas, are noncancerous uterine tumors that can cause heavy menstrual bleeding and painful periods. The condition can affect up to 80% of women by the age of 50.
In Elaris UF-II, or the M12-817 study, 76.2% of the patients experienced a reduction in heavy menstrual bleeding after six months of elagolix treatment, compared to the placebo's 10.1%.
At six months, the drug also met its secondary goals in measures of bleeding, bleeding suppression and hemoglobin changes.
Results of the study are consistent with those of the Elaris UF-I study, the first of the two phase 3 studies, which showed that elagolix was better at reducing heavy menstrual bleeding in women with uterine fibroids when combined with hormone therapy.
North Chicago, Ill.-based AbbVie said the data from the Elaris UF-II trial will be used to back its regulatory applications for the drug.
The company is developing elagolix in partnership with Neurocrine Biosciences Inc.
