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