Xanodyne Receives FDA Approval For Lysteda

Xanodyne pharmaceuticals has received the FDA approval for its Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilising a protein that helps blood to clot.

Tranexamic acid was first approved by the FDA in 1986 as an injection, under the brand name Cyklokapron, and 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. There was a statistically significant reduction in menstrual blood loss in women who received Lysteda, compared with those taking an inactive pill (placebo).