Xanodyne Announces FDA Approval of Lysteda(TM) for Treatmentof Women with Heavy Menstrual Bleeding
Mon, 11/16/2009 - 3:54am
Xanodyne Pharmaceuticals, Inc., anintegrated specialty pharmaceutical company with both development andcommercial capabilities focused on women's healthcare and pain management,announced today that Lysteda(TM) (tranexamic acid) oral tablets has receivedU.S. Food and Drug Administration (FDA) approval for treatment of womensuffering from cyclic heavy menstrual bleeding (HMB), also known asmenorrhagia. Lysteda was approved following a Priority Review by FDA and is afirst-in-class non-hormonal, oral therapeutic agent indicated specifically forthis condition. "We are very pleased with the U.S. approval of Lysteda, which representsan important new non-hormonal treatment option for women suffering from heavymenstrual bleeding," said Dr. Gary A. Shangold, Chief Medical Officer,Xanodyne. "Lysteda is a significant addition to Xanodyne's emerging productportfolio and represents the company's second FDA drug approval within fivemonths." Heavy menstrual bleeding is a persistent and recurrent medical conditionthat is one of the most common complaints encountered by gynecologists andprimary care physicians. In the United States, this medical condition affectsabout 10 percent of women of reproductive age. It is described as regularintervals of menstruation with excessive volume that may exceed 80 millilitersof blood loss per menstrual cycle. HMB is often associated with a disruptionin daily routines leading to a significant decrease in health-related qualityof life and time lost from work or school. An abnormally high rate of clot breakdown (fibrinolysis) in the uterus hasbeen associated with heavy menstrual bleeding. As an anti-fibrinolytic,Lysteda works to reduce this excessive activity, thereby helping to supportone of the important natural mechanisms by which menstrual blood flow normallystops each month. Until today, no pharmacotherapy which works through thismechanism has ever been approved by the FDA specifically for the treatment ofthis condition. "Heavy menstrual bleeding is a very common gynecologic problem," said Dr.Daniel R. Mishell Jr., The Lyle G. McNeile Professor and former Chairman ofObstetrics and Gynecology at the Keck School of Medicine, University ofSouthern California. "This disorder impairs women's activity and quality oflife. The FDA's approval of Lysteda to treat heavy menstrual bleedingprovides clinicians with a new therapeutic option to help women with heavybleeding." In the clinical trials which were the basis for Lysteda's approval, therewas a statistically significant reduction in menstrual blood loss in women whoreceived Lysteda, compared with those taking an inactive tablet (placebo).The most common adverse reactions reported during clinical trials by patientsusing Lysteda included headache, sinus and nasal symptoms, back pain,abdominal pain, muscle and joint pain, muscle cramps, anemia, and fatigue.Concomitant use of hormonal contraceptives and Lysteda may further exacerbatethe increased risk of blood clots, stroke, or heart attack known to beassociated with hormonal contraceptives. Therefore, though there are noclinical trial data on the risk of thrombotic events with the concomitant usewith hormonal contraceptives, women using hormonal contraception should takeLysteda only if there is a strong medical need, and if the benefit oftreatment will outweigh the potential increased risk.