October 6, 2010
OBSTETRICS AND GYNECOLOGY PUBLISHES DATA FROM PIVOTAL PHASE 3 LYSTEDA STUDY
First-ever, FDA-Approved Non-hormonal Treatment Option for Heavy Menstrual Bleeding
Parsippany, NJ – October 6, 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.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 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.
LYSTEDATM (tranexamic acid) tablets are indicated for the treatment of cyclic heavy menstrual bleeding. Prior to prescribing LYSTEDA, exclude endometrial pathology that can be associated with heavy menstrual bleeding. For more information, visit www.lysteda.com.
Important Safety Information
LYSTEDA is contraindicated in women with active thromboembolic disease or a history or intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion; or known hypersensitivity to tranexamic acid. Concomitant therapy with hormonal contraceptives may further increase the risk of blood clots, stroke, and myocardial infarction.
Women using hormonal contraception should use LYSTEDA only if there is a strong medical need and the benefit of treatment will outweigh the potential increased risk of a thrombotic event. In case of severe allergic reaction, discontinue LYSTEDA and seek immediate medical attention. Visual or ocular adverse effects may occur with LYSTEDA. Immediately discontinue use if visual or ocular symptoms occur. Concomitant use of LYSTEDA with Factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acids (oral tretinoin) may increase risk of thrombosis. Cerebral edema and cerebral infarction may be caused by use of LYSTEDA in women with subarachnoid hemorrhage.
The most common adverse reactions in clinical trials (> 5%, and more frequent in LYSTEDA subjects compared to placebo subjects) were: headache, sinus and nasal symptoms, back pain, abdominal pain, musculoskeletal pain, joint pain, muscle cramps, migraine, anemia and fatigue.
About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of products in the U.S. market. They include: BRAVELLE® (urofollitropin for injection, purified), MENOPUR® (menotropins for injection, USP) and REPRONEX® (menotropins for injection, USP), NOVAREL® (chorionic gonadotropin for injection, USP), ENDOMETRIN® (progesterone) Vaginal Insert, 100 mg, FIRMAGON® (degarelix for injection), PROSED® DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA® (1% sodium hyaluronate).
*LYSTEDA is contraindicated in women with active thromboembolic disease or a history or intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion; or known hypersensitivity to tranexamic acid. Concomitant use of LYSTEDA™ with hormonal contraceptives may further increase the risk of blood clots, stroke and myocardial infarction.
Please visit www.lysteda.com for Full Prescribing Information.
|1||U.S. Census Bureau, 2006-2008 American Community Survey. Available at: http://factfinder.census.gov/. Accessed April 7, 2010.|
|2||Tufts Medical Center website. Heavy Menstrual Bleeding. Available at: www.tufts-nemc.org. Accessed April 7, 2010.|