Help is on the way for some 3 million U.S. women of reproductive age who suffer from heavy menstrual bleeding, a condition also known as menorrhagia. Research into the treatment of this medical condition has led to the recent approval by the U.S. Food and Drug Administration (FDA) of a new drug as the first non-hormonal therapy for menorrhagia.
The number of American women who experience menorrhagia is based on estimates from annual reports to the FDA, and according to the agency, many of these women develop the condition with no apparent cause. Menorrhagia is an abnormally heavy and prolonged menstrual period that occurs at regular intervals. Possible causes include abnormal blood clotting, disruption of normal hormonal regulation of periods, and disorders of the endometrial lining of the uterus.
Menorrhagia is the most common type of abnormal uterine bleeding, and may sometimes become so severe as to interrupt daily activities. In addition, it may be associated with abnormally painful periods, a condition known as dysmenorrhea. According to Kathleen Uhl, M.D., the FDA’s associate commissioner of women’s health, “Menorrhagia can be incapacitating for some women.” She also added, “Heavy menstrual periods can cause pain, mood swings, and disruptions to work and family life.”
The newly FDA approved tranexamic acid, also known as Lysteda, is made is by Newport, Kentucky-based Xanodyne Pharmaceuticals. Lysteda tablets reduce the menstrual flow by working to stabilize a protein that helps blood clot. The FDA first approved the drug in 1986 under the brand name Cyklokapron as an injection for use in the reduction or prevention of bleeding during and following tooth extraction in patients with hemophilia. Hemophilia is a genetic disorder that prevents blood from clotting.
The FDA approved Lysteda based on a request submitted by Xanodyne Pharmaceuticals on January 30, 2009 after completing phase 3 of clinical trials during which women took either Lysteda or a placebo. Findings showed a statistically significant reduction in menstrual blood loss in women who received Lysteda compared with those taking placebo. Common side effects of Lysteda included headache, sinus and nasal symptoms, back or abdominal pain, muscle or joint pain, anemia and fatigue.
According to Scott Monroe, M.D., director of the division of reproductive and urologic products in the FDA's Center for Drug Evaluation and Research, women who take Lysteda should avoid the use of hormonal contraceptive drugs, as this drug combination can increase the risk of blood clots, stroke and heart attacks. These medications should only be used together if there is a strong medical need, and if the benefit of treatment will outweigh the potential increased risk.
Founded in 2001, Xanodyne Pharmaceuticals specializes in development and marketing of drugs for pain management and women’s healthcare including prescription pharmaceuticals, as well as a line of prenatal vitamins. Regarding the FDA’s recent approval, Dr. Gary A. Shangold, Chief Medical Officer of Xanodyne, said “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.” He also pointed out, “Lysteda is a significant addition to Xanodyne’s emerging product portfolio and represents the company’s second FDA drug approval within five months.”
