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(TM) (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.