Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

Ferring Pharmaceuticals Inc. announced today the U.S. commercial availability of LYSTEDA™ (tranexamic acid) tablets, the only non-hormonal and non-surgical therapy indicated specifically for the treatment of women with cyclic heavy menstrual bleeding (HMB).  In clinical studies, LYSTEDA significantly reduced menstrual blood loss (MBL) over three and six cycles of use with the reduction seen as early as the first cycle of use.  It also significantly reduced limitations on social, leisure and physical activities in women with cyclic HMB.  It is estimated that up to 22 million women suffer from HMB in the U.S.

"Heavy menstrual bleeding is a common condition that can significantly interfere with a woman's daily activities.  Many women consider the condition normal and are unaware that there are treatments available, so they don't ask their doctor about it," said Edward A. Trott, MD, Vice President of Medical Affairs, Ferring Pharmaceuticals.  "Now, LYSTEDA is available for appropriate women who suffer from cyclic heavy menstrual bleeding.  It is a convenient treatment that can reduce menstrual flow by nearly 40 percent without taking the extra hormones in birth control pills or undergoing surgery.  The tablets are taken only during the menstrual period for up to five days, and have been shown to work within the first cycle of use."

LYSTEDA's safety and efficacy for treating cyclic HMB were tested in a 3-cycle study of 294 women and a 6-cycle study of 187 women.  Both were randomized, double-blind, placebo-controlled studies in women ages 18-49 with HMB.  HMB was defined as mean menstrual blood loss greater than 80 mL per cycle, averaged over 2 cycles and measured by a validated alkaline hematin method.  In both studies, MBL was statistically significantly reduced in patients treated with 3,900 mg a day of LYSTEDA compared to placebo.  The reduction in MBL in the 3-cycle study was 39% compared to 5% with placebo and in the 6-cycle study, 38% compared to 12% with placebo.  In both studies, LYSTEDA also statistically significantly reduced limitations on social, leisure, and physical activities, thereby making a meaningful difference during a woman's cycle.

LYSTEDA oral tablets received approval on November 13, 2009, following a Priority Review by the U.S. Food and Drug Administration (FDA).  Ferring acquired the global rights to LYSTEDA from Xanodyne Pharmaceuticals on May 7, 2010, expanding its Women's Health product portfolio.