June 21, 2010
Ferring Pharmaceuticals Announces Immediate Availability Of Lysteda™, The First Non-Hormonal Therapy Indicated Specifically For Cyclic Heavy Menstrual Bleeding
Information for Patients and Physicians Available at www.lysteda.com
Parsippany, NJ – June 21, 2010 – 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.1,2
“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.
For more information about LYSTEDA and/or to receive a patient savings certificate, please visit www.lysteda.com.
About Heavy Menstrual Bleeding
HMB is a condition in which patients have higher levels of plasminogen activators than women with normal bleeding.3 For women with HMB, the activated plasmin disrupts the fibrin mesh which leads to a more rapid breakdown of the blood clot.3 HMB is defined as regular, normal intervals of menstruation with excessive volume exceeding 80 mL of blood loss per cycle, or menses lasting more than seven days.4 Excessive volume may mean menstrual flow that soaks through one or more sanitary pads or tampons per hour.5 Other signs may be menstrual flow with large blood clots, the need to change sanitary protection during the night, and tiredness, fatigue or shortness of breath.5 HMB can lead to iron deficiency anemia in up to 67% of cases.6
For some women, HMB can be incapacitating. It affects social, leisure and physical activities such as: ability to manage household duties; playing with children/attending school functions; exercising and playing sports; work; and sexual intimacy. Patients with HMB are also concerned about staining their clothes, undergarments, sheets, and upholstery.
LYSTEDA™ (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).
Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, orthopaedics, gastroenterology, obstetrics/gynecology, and infertility. For more information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.
|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.|
|3||Lethaby A, Farquhar C, Cooke I. Antifibrinolytics for heavy menstrual bleeding (Review). Cochrane Database Syst Rev. 2000; CD000249:1-35.|
|4||Agpar BS, Kaufman AH, Uche G-N, et al. Treatment of Menorrhagia. Amer Fam Phys. 2007; 75:1813-1819.|
|5||Mayo Clinic Website. Menorrhagia. Available at www.mayoclinic.com/health/menorrhagia. Accessed May 12, 2010.|
|6||Hallberg L, Hogdahl AM, Nilsson L, et al. Menstrual blood loss – a population study. Variation at different ages and attempts to define normality. Acta Obstet Gynecol Scand. 1966; 45:320-351.|