Meditrina Pharmaceuticals, Inc. Opens Investigational New Drug (IND) Application for Phase IIb Clinical Trial With MPI-676 in End...(nging trial willinclude three treatment ...),Health

Date:7/17/2008

nging trial will include three treatment arms of anastrozole, all with a fixed dose oral contraceptive in pre-menopausal women diagnosed with endometriosis. The primary endpoint is reduction in endometriosis-related symptoms, primarily pain. Secondary endpoints include quality of life, bleeding patterns and safety outcomes. The goal of the study is to provide data on efficacy and safety of MPI-676, as well as information about feasible endpoints and trial sizes for the planning and execution of the subsequent pivotal Phase III program in endometriosis.

Endometriosis is a serious medical condition where endometrial stroma and glands that are normally present in the uterine cavity are found in other parts of the body. Endometriosis lesions can be found anywhere in the pelvic cavity. The most common symptom of endometriosis is pelvic pain, which often correlates to the menstrual cycle, but a woman with endometriosis may also experience pain that doesn't correlate to her cycle. For many women, the pain of endometriosis is so severe and debilitating that it significantly impacts their daily lives.

It is estimated that seven to 10 percent of all women are affected by endometriosis, including 70 to 87 percent of women with chronic pelvic pain and 30 to 40 percent of all infertile women. Chronic pelvic pain, dysmenorrhea (painful periods) and dyspareunia (painful intercourse) are common symptoms of women with endometriosis. There are several medical treatment options, including danazol, GnRH agonists and progestins, each of which have limitations associated with patient response, tolerability, side-effect profile and duration of treatment.

About Femathina(TM) (MPI-674) and MPI-676

Femathina(TM) (MPI-674) and MPI-676 are based on anastrozole, an aromatase inhibitor (AI) with well-established, multi-year chronic safety and tolerability data. AIs are a class of drugs that reduce the amount of estrogen circulating in the body by binding to and inhibi
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