Aug 05 2008
NEWPORT, Kentucky—Xanodyne Pharmaceuticals, Inc. announced today positive top line results in two pivotal Phase 3 clinical trials of its proprietary investigational product, a modified-release (MR) formulation of tranexamic acid for the treatment of women with menorrhagia, or heavy menstrual bleeding, and its accompanying symptoms.
“We are extremely pleased with the initial data from these pivotal trials and we look forward to continuing to work with the U.S. Food and Drug Administration (FDA) to complete the registration process for what we hope may be an important new therapeutic approach to treating this disabling condition,” said Gregory D. Flexter, President and Chief Executive Officer of Xanodyne.
In addition to these two recently completed Phase 3 clinical trials, which evaluated the efficacy and safety of tranexamic acid MR, two additional open-label safety trials are ongoing. The four clinical trials represent the basis for Xanodyne’s planned filing of a new drug application (NDA) with the FDA.
In each of the two placebo-controlled efficacy and safety trials, patients treated with tranexamic acid MR experienced a significant reduction in mean monthly menstrual blood loss compared with baseline pre-treatment blood loss, during three and six cycles of treatment (p<0.0001), respectively. This reduction was further judged to be meaningful by the women in the trials. Further analysis of the complete safety and efficacy data from these four trials is on-going.
“The achievement of this important clinical milestone for tranexamicacid MR is a significant advance in our efforts to bring forward an important treatment option for women suffering from menorrhagia. We are hopeful that this product candidate, along with the pro-drug of tranexamic acid that we recently licensed from XenoPort, Inc., may provide healthcare
providers and patients with the potential for a series of future treatment options for serious conditions impacting the health of women,” said Gary A. Shangold, MD, Chief Medical Officer of Xanodyne.
Xanodyne is currently targeting the submission of an NDA in early 2009. If ultimately approved, this product candidate could become the first approved pharmaceutical product in the United States specifically indicated for the treatment of menorrhagia.
Heavy menstrual bleeding, or menorrhagia, represents a frequent and significant medical condition encountered by obstetricians, gynecologists and primary care physicians. Menorrhagia has been described as regular, normal intervals of menstruation with volume that may exceed 80 milliliters of blood loss per menstrual cycle.
Xanodyne Pharmaceuticals, Inc., which commenced operations in 2001, is an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women’s healthcare and pain management. Xanodyne markets a portfolio of revenue generating products consisting of FDA approved pharmaceuticals and a line of prenatal vitamins. Additionally, Xanodyne is advancing a late stage pipeline of product candidates targeted at significant potential markets in Xanodyne’s focus areas.
SOURCE Xanodyne Pharmaceuticals, Inc.
Thomas P. Jennings, General Counsel, Xanodyne
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