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news.Xanodyne Pharmaceuticals has reported positive top-line results from two pivotal Phase III clinical trials of its proprietary investigational product, a modified-release formulation of tranexamic acid for the treatment of women with menorrhagia, or heavy menstrual bleeding, and its accompanying symptoms.
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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.
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.
In addition to these two recently completed Phase III clinical trials, which evaluated the efficacy and safety of tranexamic acid modified-release (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.
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 US specifically indicated for the treatment of menorrhagia.
Gregory Flexter, president and CEO of Xanodyne, said: “We are extremely pleased with the initial data from these pivotal trials and we look forward to continuing to work with the FDA to complete the registration process for what we hope may be an important new therapeutic approach to treating this disabling condition.”