Obstetrics and Gynecology Publishes Data From Pivotal Phase 3 LYSTEDA Study
PARSIPPANY, N.J., Oct. 6 /PRNewswire/ -- 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.(1,2)
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) (n=115) or placebo (n=72) for up to 5 days per menstrual cycle through six cycles. The LYSTEDA group had a significantly greater reduction in menstrual blood loss of 69.6 mL (40.4%) compared with 12.6 mL (8.2%) in the placebo group (p<.001). This reduction in menstrual blood loss was considered meaningful to women. Women taking LYSTEDA also experienced significant improvements in limitations in social, leisure and physical activities, measured using the Menorrhagia Impact Questionnaire (MIQ), a validated patient-reported outcome instrument, to measure changes at baseline and after three treatment menstrual cycles.
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