May 4, 2011
RETROSPECTIVE ANALYSIS EXPLORES LYSTEDA®’S ABILITY TO REDUCE SLEEP INTERRUPTIONS IN WOMEN WITH CYCLIC HEAVY MENSTRUAL BLEEDING
Findings presented at The American College of Obstetricians and Gynecologists’ 59th Annual Clinical Meeting
Washington, DC – May 4, 2011 – Cyclic heavy menstrual bleeding (HMB) has been reported to significantly impact a woman’s ability to get uninterrupted sleep which can often lead to daytime fatigue and irritability.1 According to a recent retrospective analysis of the 6-cycle pivotal trial that supported product approval, women taking LYSTEDA® (tranexamic acid) Tablets, 3.9 g/day, experienced a 0.99 mean reduction in the number of sleep interruptions over baseline (1.65) compared with a 0.70 mean reduction over baseline (1.92) for women in the placebo group (P=.0024). LYSTEDA is a non-hormonal and non-surgical therapy specifically indicated for women with heavy menstrual bleeding that is taken only during menstruation.
The findings of the LYSTEDA study were presented in a poster at The American College of Obstetricians and Gynecologists’ 59th Annual Clinical Meeting in Washington, DC, April 30 – May 4, 2011.
“Women who experience heavy menstrual bleeding often present to a healthcare provider because of the subsequent negative impact on their daily lives and activities,” said Ken Muse, MD, lead study investigator and Associate Professor of Obstetrics and Gynecology, University of Kentucky. “Sleep interruptions caused by waking in the night to change sanitary products are often an under-recognized consequence of cyclic heavy menstrual bleeding.”
According to the investigators, LYSTEDA was generally well tolerated with adverse events in the trial similar to placebo. LYSTEDA is a non-hormonal prescription medication for HMB which has been shown to be effective in reducing menstrual blood loss beginning as early as the first cycle of treatment and which can be comfortably taken long term.
About the Study
This was a retrospspective analysis of the randomized, placebo-controlled, parallel group study which was conducted in 187 women (18-49 years old) with cyclic HMB. Women were randomized to receive either 3.9 g/day of LYSTEDA or placebo for up to five days at the onset of HMB. Women continued in treatment for six cycles. Patients recorded sleep disturbances in diaries during each menstrual period.
LYSTEDA is the only oral non-hormonal and non-surgical prescription medicine FDA-approved specifically to treat HMB. In the 6-cycle treatment study, LYSTEDA significantly reduced menstrual blood loss by 38% compared to 12% with placebo. Patients experienced full clinical efficacy as early as the first menstrual cycle which was maintained throughout all cycles studied. LYSTEDA also significantly reduced limitations on social, leisure and physical activities during a woman’s cycle. LYSTEDA tablets are taken only during the menstrual cycle for up to five days. Long-term treatment with LYSTEDA has been shown to be safe and well-tolerated in more than 10,000 cycles studied.
LYSTEDA 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. LYSTEDA has not been studied in adolescents under age 18 with heavy menstrual bleeding.
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. The risk of thrombotic and thromboembolic events may increase further when hormonal contraceptives are administered with LYSTEDA, especially in women who are obese or smoke cigarettes. 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. Do not use LYSTEDA in women who are taking more than the approved dose of a hormonal contraceptive. Concomitant use of LYSTEDA with Factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid (oral tretinoin) may increase risk of thrombosis. Visual or ocular adverse effects may occur with LYSTEDA. Immediately discontinue use if visual or ocular symptoms occur. In case of severe allergic reaction, discontinue LYSTEDA and seek immediate medical attention. Cerebral edema and cerebral infarction may be caused by use of LYSTEDA in women with subarachnoid hemorrhage. Ligneous conjunctivitis has been reported in patients taking tranexamic acid. 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: LYSTEDA tablets, 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.
Please visit www.lysteda.com for Full Prescribing Information.
|1||Findings from “Living with Heavy Menstrual Bleeding – A National Survey of 500 U.S. Women,” conducted online in June 2010 by Harris Interactive, Inc., on behalf of Ferring Pharmaceuticals Inc.|