PregLem announces positive phase III results for Esmya as a treatment for uterine fibroids

PEARL II study meets both primary efficacy and safety endpoints

19-May-2010 - Switzerland

PregLem announced positive Phase III results of EsmyaTM(ulipristal acetate) for the treatment of symptomatic uterine fibroids (myoma). The PEARL II study assessed the efficacy and safety of EsmyaTMcompared to the only currently approved treatment, a GnRH (gonadotropin-releasing hormone) agonist.

The PEARL II study was designed to assess the efficacy and safety of EsmyaTM, an oral therapy, compared to the injectable GnRH agonist Leuprorelin, for the treatment of symptomatic uterine fibroids in patients eligible for surgery. This randomised, parallel group, double-blind, double-dummy, multi-center study involved a total of 307 patients and compared EsmyaTM 5mg or 10mg orally, once-a-day with Leuprorelin 3.75 mg monthly injections.

The study met its primary efficacy and safety endpoints. EsmyaTM met the pre-defined, non inferiority efficacy endpoint versus Leuprorelin to reduce excessive uterine bleeding caused by uterine myomas. The primary endpoint was change from baseline in the bleeding intensity score. This was measured as a percentage of patients with a reduction of PBAC (Pictorial Blood Assessment Chart) score to lower than 75 after 3 months of treatment. EsmyaTM demonstrated superior safety and tolerance with statistical significance versus Leuprorelin regarding castration-related symptoms and their consequences. The principal parameters were serum oestradiol levels and hot flushes.

Professor Jacques Donnez, from Louvain University (Belgium), the Principal investigator said: “These data are very promising. There has been a lack of innovative and effective products to treat uterine fibroids. This is a significant and distressing problem for many women and has a serious impact on their lives. These results clearly illu

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