NEWPORT, Ky., Aug. 5 Xanodyne Pharmaceuticals, Inc.announced today positive top line results in two pivotal Phase 3 clinicaltrials of its proprietary investigational product, a modified-release (MR)formulation of tranexamic acid for the treatment of women with menorrhagia, orheavy menstrual bleeding, and its accompanying symptoms.
"We are extremely pleased with the initial data from these pivotal trialsand we look forward to continuing to work with the U.S. Food and DrugAdministration (FDA) to complete the registration process for what we hope maybe an important new therapeutic approach to treating this disablingcondition," said Gregory D. Flexter, President and Chief Executive Officer ofXanodyne.
In addition to these two recently completed Phase 3 clinical trials, whichevaluated the efficacy and safety of tranexamic acid MR, two additionalopen-label safety trials are ongoing. The four clinical trials represent thebasis for Xanodyne's planned filing of a new drug application (NDA) with theFDA.
In each of the two placebo-controlled efficacy and safety trials, patientstreated with tranexamic acid MR experienced a significant reduction in meanmonthly menstrual blood loss compared with baseline pre-treatment blood loss,during three and six cycles of treatment (p<0.0001), respectively. Thisreduction was further judged to be meaningful by the women in the trials.Further analysis of the complete safety and efficacy data from these fourtrials is on-going.
"The achievement of this important clinical milestone for tranexamic acidMR is a significant advance in our efforts to bring forward an importanttreatment option for women suffering from menorrhagia. We are hopeful thatthis product candidate, along with the pro-drug of tranexamic acid that werecently licensed from XenoPort, Inc., may provide healthcare providers andpatients with the potential for a series of future treatment options forserious 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 approvedpharmaceutical product in the United States specifically indicated for thetreatment of menorrhagia.
Heavy menstrual bleeding, or menorrhagia, represents a frequent andsignificant medical condition encountered by obstetricians, gynecologists andprimary care physicians. Menorrhagia has been described as regular, normalintervals of menstruation with volume that may exceed 80 milliliters of bloodloss per menstrual cycle.
Xanodyne Pharmaceuticals, Inc., which commenced operations in 2001, is anintegrated specialty pharmaceutical company with both development andcommercial capabilities focused on women's healthcare and pain management.Xanodyne markets a portfolio of revenue generating products consisting of FDAapproved pharmaceuticals and a line of prenatal vitamins. Additionally,Xanodyne is advancing a late stage pipeline of product candidates targeted atsignificant potential markets in Xanodyne's focus areas.
SOURCE Xanodyne Pharmaceuticals, Inc.