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FDA Approves Lysteda

Xanodyne Announces FDA Approval of Lysteda (Tranexamic Acid) for Treatment of Women with Heavy Menstrual Bleeding

NEWPORT, Ky., Nov. 16 /PRNewswire/ -- Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today that Lysteda (tranexamic acid) oral tablets has received U.S. Food and Drug Administration (FDA) approval for treatment of women suffering from cyclic heavy menstrual bleeding (HMB), also known as menorrhagia. Lysteda was approved following a Priority Review by FDA and is a first-in-class non-hormonal, oral therapeutic agent indicated specifically for this condition.

"We are very pleased with the U.S. approval of Lysteda, which represents an important new non-hormonal treatment option for women suffering from heavy menstrual bleeding," said Dr. Gary A. Shangold, Chief Medical Officer, Xanodyne. "Lysteda is a significant addition to Xanodyne's emerging product portfolio and represents the company's second FDA drug approval within five months."

Heavy menstrual bleeding is a persistent and recurrent medical condition that is one of the most common complaints encountered by gynecologists and primary care physicians. In the United States, this medical condition affects about 10 percent of women of reproductive age. It is described as regular intervals of menstruation with excessive volume that may exceed 80 milliliters of blood loss per menstrual cycle. HMB is often associated with a disruption in daily routines leading to a significant decrease in health-related quality of life and time lost from work or school.

An abnormally high rate of clot breakdown (fibrinolysis) in the uterus has been associated with heavy menstrual bleeding. As an anti-fibrinolytic, Lysteda works to reduce this excessive activity, thereby helping to support one of the important natural mechanisms by which menstrual blood flow normally stops each month. Until today, no pharmacotherapy which works through this mechanism has ever been approved by the FDA specifically for the treatment of this condition.

"Heavy menstrual bleeding is a very common gynecologic problem," said Dr. Daniel R. Mishell Jr., The Lyle G. McNeile Professor and former Chairman of Obstetrics and Gynecology at the Keck School of Medicine, University of Southern California. "This disorder impairs women's activity and quality of life. The FDA's approval of Lysteda to treat heavy menstrual bleeding provides clinicians with a new therapeutic option to help women with heavy bleeding."

In the clinical trials which were the basis for Lysteda's approval, there was a statistically significant reduction in menstrual blood loss in women who received Lysteda, compared with those taking an inactive tablet (placebo). The most common adverse reactions reported during clinical trials by patients using 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 exacerbate the increased risk of blood clots, stroke, or heart attack known to be associated with hormonal contraceptives. Therefore, though there are no clinical trial data on the risk of thrombotic events with the concomitant use with hormonal contraceptives, women using hormonal contraception should take Lysteda only if there is a strong medical need, and if the benefit of treatment will outweigh the potential increased risk.

About Xanodyne

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 products consisting of prescription 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.

Posted: November 2009

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