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Clinical Data Demonstrates That LYSTEDA™ Significantly Reduced Menstrual Blood Loss and Limitations on Social, Leisure and Physical Activities in Women With Cyclic HMB
Date:5/19/2010

hey experienced a significant, meaningful improvement in their social, leisure and physical activities."

Edward A. Trott, MD, Vice President of Medical Affairs, Ferring Pharmaceuticals, stated, "Heavy menstrual bleeding has long been a widely overlooked and unmet medical need that many women considered normal and did not require special medication.  With the introduction of LYSTEDA, obstetricians and gynecologists can now offer appropriate patients the only non-hormonal therapy that is FDA approved for cyclic heavy menstrual bleeding and taken only during the menstrual phase."

The following results of the oral tranexamic acid formulation (LYSTEDA) were reported from two multicenter, double-blind, placebo-controlled, parallel-group trials of women aged 18-49 years with HMB, defined as mean menstrual blood loss (MBL) greater than 80 mL per cycle, averaged over two cycles and measured by a validated alkaline hematin method.

Dose-Response Analysis

To assess the efficacy and safety of two dosage regimens, 294 women with HMB were randomized (2:2:1) to receive LYSTEDA 1.95 (n=115) or 3.9 g/day (n=112) or placebo (n=67) for up to five days of menstrual bleeding.  MBL was measured during 2 baseline and 3 treatment cycles using a validated alkaline hematin method.  The tripartite primary efficacy endpoint was achieved if MBL reduction from baseline was significantly greater than placebo, met a "meaningful" reduction in MBL threshold of 36 mL/cycle as perceived by women with HMB, and exceeded 50 mL/cycle.

Only women receiving LYSTEDA 3.9 g/day achieved the tripartite endpoint.  Mean reduction of MBL for the 3.9 g/day group was -65.3 mL/cycle compared with -3.0 mL/cycle for women receiving placebo (P<.001).  Both doses of LYSTEDA were well tolerated.


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SOURCE Ferring Pharmaceuticals Inc.
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