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news.Xanodyne Pharmaceuticals, an integrated specialty pharmaceutical company, has reported that the FDA has accepted for filing and granted priority review status for its investigational proprietary formulation of tranexamic acid for the treatment of women with menorrhagia, heavy menstrual bleeding and its accompanying symptoms.
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Under the Prescription Drug User Fee Act, drug products with priority review designation have a six month review clock as compared to a 10 month standard review. Upon approval, this product candidate could become the first approved pharmaceutical product in the US specifically indicated for the treatment of menorrhagia.
Earlier, Xanodyne submitted the new drug application for XP12B, a unique oral therapy which acts as a competitive plasmin inhibitor to prevent fibrinolysis by binding to the lysine receptor sites of plasminogen. This helps to normalize the hyperfibrinolytic activity often present in women with heavy menstrual bleeding (HMB).
Gary Shangold, chief medical officer of Xanodyne, said: “We are pleased with the position that the FDA has taken in granting XP12B a priority review as it reflects their recognition of the important unmet medical need which HMB represents. We look forward to working closely with the agency to further advance this important treatment option to women who suffer from menorrhagia, or heavy menstrual bleeding.”