Watson commences US Phase III study of Esmya
Watson Pharmaceuticals has begun its Phase 3 trial to investigate the efficacy and safety of Esmya (ulipristal acetate) in women with anemia associated with uterine leiomyomas.
Esmya is a first-in-class, orally active selective progesterone receptor modulator which reversibly blocks progesterone receptors in target tissues.
The multi-center randomized double-blind US Phase 3 study included 300 subjects, aged 18-50 years to assess the safety and efficacy of ulipristal acetate 10mg in women with anemia associated uterine leiomyomas.
In the study, subjects will be randomized to receive ulipristal acetate 10mg plus iron or matching placebo plus iron, administered orally, once daily over three consecutive menstrual cycles.
Efficacy and safety measurements will include change from baseline in hemoglobin at the start, or scheduled start, of menstrual cycle 3, and overall bleeding assessments through the end of treatment using a subject-maintained Menstrual Cycle Bleeding Diary.
Watson Global Brands executive vice president Fred Wilkinson said initiation of the US pivotal trial is underway on schedule and they hope that this Phase 3 study will demonstrate improvement on pre-surgical hemoglobin concentrations, an endpoint indicating that heavy bleeding and anemia have been alleviated.
European Commission has approved Esmya 5mg tablet for pre-operative treatment of moderate-to-severe symptoms of uterine fibroids.
The company anticipates the Phase 3 trial to be completed by Q4, 2013, at which time it will prepare a New Drug Application for submission to the US Food and Drug Administration.