October 17, 2011
RETROSPECTIVE ANALYSIS EVALUATES THE EFFECT OF LYSTEDA® ON THE NUMBER OF SLEEP INTERRUPTIONS FOR WOMEN WITH CYCLIC HEAVY MENSTRUAL BLEEDING
Findings presented at Nurse Practitioners in Women’s Health 14th Annual Premier Women’s HealthCare Conference
AUSTIN, TX – October 17, 2011 – According to a recent combined retrospective analysis of women with cyclic heavy menstrual bleeding*, LYSTEDA® (tranexamic acid) tablets significantly reduced the number of sleep interruptions during the night compared with placebo (-2.61 vs -1.81, respectively). The study results were presented at the Nurse Practitioners in Women’s Health 14th Annual Premier Women’s HealthCare Conference in Austin, TX, October 12-15, 2011. LYSTEDA is the only non-hormonal prescription medicine FDA-approved specifically to treat cyclic heavy menstrual bleeding.
“These preliminary findings are of interest because women who suffer from heavy periods often report that their day-to-day functioning is severely impacted because of their lack of ability to get a restful night sleep,” said Scott Eder, MD, lead study investigator, Women’s Health Research Center in Plainsboro, NJ. “By significantly reducing menstrual blood loss, LYSTEDA may secondarily reduce the unfortunate consequence of sleep interruptions, which can often lead to daytime fatigue and irritability. Prospective clinical trials are needed to confirm these findings.”
About the Study
The LYSTEDA sleep disturbance study is a combined retrospective analysis of the two randomized, placebo-controlled, parallel group studies which were conducted in 371 women (18-49 years old) with cyclic HMB (LYSTEDA n=232, placebo n=139). In the first study, women were randomized (2:2:1) to receive LYSTEDA 1.95 g/day or 3.9 g/day or placebo for up to five days per menstrual period for three cycles. In the second study, after two pre-treatment menstrual cycles, women were randomized to receive LYSTEDA 3.9 g/day or placebo for up to five days per menstrual period for six cycles. The rates of discontinuation due to adverse events during the two clinical trials were low and comparable between LYSTEDA and placebo.
The most common adverse reactions (≥ 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. This analysis presents combined data for subjects from both studies receiving either LYSTEDA 3.9 g/day (the approved dosage that met the efficacy endpoints) or placebo. Women recorded nightly sleep disturbances in diaries during each menstrual cycle. The mean number of sleep interruptions in the LYSTEDA group (2.36 [3.24]) was significantly lower (P < .001) compared with the placebo group (3.61 [3.75]).
LYSTEDA is a non-hormonal prescription medication for cyclic heavy menstrual bleeding which has been shown to be effective in reducing menstrual blood loss (MBL) beginning as early as the first cycle of treatment and which can be comfortably taken long term.
LYSTEDA is a reformulation of tranexamic acid specifically developed for excessive menstrual bleeding. Tranexamic acid has been used for decades to control excessive bleeding. It received the first approval in the United States in 1986 as an injectable for excessive dental bleeding. LYSTEDA works by slowing the breakdown of the fibrin matrix that occurs after coagulation, which helps reduce excessive bleeding in women with heavy periods. Since LYSTEDA acts downstream from the coagulation cascade to lighten heavy periods, it can’t induce, increase, or accelerate clot formation. LYSTEDA helps to preserve the fibrin matrix, thereby reducing heavy menstrual bleeding. If a patient were to have a spontaneous thrombus independent of LYSTEDA, the breakdown of that thrombus could potentially be slowed by LYSTEDA. Because women with a history of thromboembolic disease have an increased risk for a spontaneous thrombus, they should not take LYSTEDA.
In two Phase 3 randomized, double-blind, placebo-controlled trials of women aged 18-49 years with heavy menstrual bleeding, LYSTEDA (3900 mg/day) significantly reduced MBL over three cycles (n=294) and six cycles (n=187). Patients experienced clinical efficacy as early as the first menstrual cycle which was consistently maintained across all cycles studied. The reduction in MBL in the 3-cycle treatment was 39% compared to 5% with placebo and in the 6-cycle treatment, 38% compared to 12% with placebo.
Limitations on social, leisure, and physical activities were also significantly reduced in patients treated with LYSTEDA compared to placebo (P < 0.05), as measured by The Menorrhagia Impact Questionnaire after the first month of treatment in the two Phase 3 trials.
LYSTEDA tablets are taken only during the menstrual cycle for up to five days.
The safety of LYSTEDA in the treatment of heavy menstrual bleeding was studied in the two randomized, double-blind, placebo-controlled trials. In these trials, women had cyclic menses every 21-35 days and a BMI of approximately 32 kg/m2. On average, subjects had a history of heavy menstrual bleeding for approximately 10 years and 40% had fibroids as determined by transvaginal ultrasound.
Long-term treatment with LYSTEDA has been shown to be safe and well-tolerated in more than 13,000 cycles studied. LYSTEDA’s safety and tolerability profile has been proven when used in patients who were taking concomitant analgesics which is especially important for those patients who require pain control due to dysmenorrhea. In a 27-cycle, open-label safety study of LYSTEDA, subjects were allowed to concomitantly use acetaminophen, ASA, opioids, COX-2 inhibitors, as well as vitamins and oral iron therapy.** The types and severity of adverse events in the long-term trial was similar to those observed in the double-blind, placebo- controlled studies although the percentage of subjects reporting them was greater, most likely because of the longer study duration.
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.
*Included three and six-cycle pivotal studies
**Study 304: Open-label study of 781 women with physician-diagnosed heavy menstrual bleeding to assess the long-term safety of LYSTEDA up to 27 cycles.
Please visit www.lysteda.com for Full Prescribing Information.