Ferring Pharmaceuticals announces publication of Phase 3 trials of LYSTEDA tablets for HMB

Oct 7 2010

Ferring Pharmaceuticals Inc. today announced publication of one of its pivotal Phase 3 trials of LYSTEDA™ (tranexamic acid) tablets for cyclic heavy menstrual bleeding (HMB) in the October issue of the peer-reviewed journal, Obstetrics & Gynecology.  The six-month clinical trial demonstrated that LYSTEDA significantly reduced menstrual blood loss from baseline, and improved health-related quality-of-life parameters in women with cyclic HMB while maintaining safety and tolerability.  It is estimated that up to 22 million women suffer from HMB in the U.S.

In the double-blind, placebo-controlled 6-month study, women ages 18-49 years with HMB, defined as mean menstrual blood loss of 80 mL or more per cycle, were randomized to receive LYSTEDA (3.9 g/d)>

LYSTEDA was generally well tolerated, and the majority of adverse events were mild to moderate in severity.  The most common adverse events reported were menstrual discomfort or cramps, headache, and back pain.

"We are excited by the results of this clinical trial.  Women receiving LYSTEDA met all three primary efficacy points: a significantly greater reduction in menstrual blood loss compared with placebo, a reduction exceeding a pre-specified volume, and most importantly, a reduction considered meaningful to women.  This latter point was further demonstrated by significant improvements in limitations in social or leisure and physical activities, and work inside or outside the home in women receiving LYSTEDA compared with those receiving placebo," stated Andrea Lukes, MD, MHSc, lead study investigator, Carolina Women's Research and Wellness Center.  "LYSTEDA offers clinicians a first-line, non-hormonal treatment option for women with cyclic heavy menstrual bleeding."

"We are pleased to present these data that add to the existing body of evidence demonstrating the safety and efficacy of LYSTEDA in the treatment of cyclic heavy menstrual bleeding," said Edward A. Trott, MD, Vice President of Medical Affairs, Ferring Pharmaceuticals Inc. "Women in the study experienced a significant reduction in menstrual blood loss, as early as the first cycle of use, which was maintained throughout all treatment cycles.  In addition to the reduction in monthly blood loss, there was a statistically significant improvement in the health-related quality-of-life parameters for social, leisure and physical activities."

LYSTEDA's Unique Mechanism of Action

LYSTEDA works to slow the breakdown of clots thereby reducing cyclic HMB.  LYSTEDA does not cause clots and has no effect on clotting factors or platelet function.

In the fibrinolytic pathway, tissue plasminogen activator binds with plasminogen, cleaving it to the active form of the enzyme plasmin.  This activated enzyme binds the fibrin mesh that holds a clot together and cleaves it, allowing the clot to break apart.  Many HMB patients have higher levels of plasminogen activators than those with normal bleeding.  For those patients, fibrinolysis breaks down the normal fibrin matrix in the endometrium, causing a more rapid breakdown of the blood clot and excessive blood loss.  LYSTEDA binds to the fibrin-binding site of plasmin, preventing it from binding to fibrin.  This allows the clot to stay in place longer, preserving and stabilizing the fibrin's matrix structure, and helps reduce bleeding.

SOURCE Ferring Pharmaceuticals Inc.