Lysteda or tranexamic acid, a non hormonal oral tablets to treat women suffering from from heavy bleeding during menstrual cycles, has been granted marketing approval in US.
US Food and Drug Administration has approved Lysteda (tranexamic acid) for treatment of women suffering from cyclic heavy menstrual bleeding (HMB), also known as menorrhagia, Xanodyne Pharmaceuticals Inc, the maker of the drug announced.
Lysteda (tranexamic acid) is a first-in-class non-hormonal, oral therapeutic agent indicated specifically for cyclic heavy menstrual bleeding.
Lysteda (tranexamic acid) was approved following a Priority Review by US FDA.
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.
Heavy menstrual bleeding affects about 10 percent of women of reproductive age, in the United States.
Heavy menstrual bleeding 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.
No drug which works through anti-fibrinolytic mechanism has ever been approved by the FDA specifically for the treatment of this condition.
Lysteda showed a statistically significant reduction in menstrual blood loss in women, compared with those taking an inactive tablet (placebo) in the clinical trials.
Tranexamic acid is not a new drug, altogether. It was first approved by the FDA in 1986 as an injection under the brand name Cyklokapron. Tranexamic acid is used to reduce or prevent bleeding during and following tooth extraction in patients with hemophilia, a hereditary bleeding disorder caused by the lack of a blood-clotting factor.
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.
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, Xanodyne alerted in a press release.
Newport, Ky.-based Xanodyne Pharmaceuticals, Inc 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.