SAN FRANCISCO, May 18 Teva Women's Health, Inc. today presented data that demonstrated patients treated with a standard or low dose of ENJUVIA® (synthetic conjugated estrogens, B) tablets experienced statistically significant reductions in how often they were awakened at night by hot flashes compared to patients treated with placebo. The data was presented today at the 58th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco.
Hot flashes, caused by menopausal hormone changes, occur in as many as 85 percent of menopausal women, and can be severe enough to negatively impact sleep. The prevalence rate of sleep problems among perimenopausal women and postmenopausal women varies from 31 to 45 percent.
This study evaluated the effectiveness of ENJUVIA (0.3mg and 0.625mg doses) over a 12-week treatment period in reducing the frequency of nighttime sleep awakenings caused by hot flashes in highly symptomatic women. These women were defined as experiencing at least three nighttime awakenings per night at baseline. The study met its primary endpoint of significantly reducing the number of awakenings in both dosing arms with the higher dose achieving a greater mean reduction of 4.56 awakenings per week (p<0.001) than the lower dose (3.55 awakenings per week, p=0.004) relative to placebo. The study did not meet its secondary endpoint of significantly improving individual sleep quality or overall daytime sleepiness as measured by the Stanford Sleepiness Scale Ratings.
"Sleep disruptions due to menopausal symptoms can adversely impact a woman's quality of life," said lead investigator James H. Liu, M.D., Arthur H. Bill Professor and Chair at the Department of Obstetrics and Gynecology at Case Western Reserve University School of Medicine in Cleveland. "These results are encouraging and show that highly symptomatic postmenopausal women who are repeatedly and routinely awakened by hot flashes night after night can find relief with ENJUVIA even at the lowest dose to regain better control over their sleep time."
Patients enrolled in the higher dose study arm showed statistically significant improvement in reduction of the frequency of awakenings starting at week four, and at weeks eight and 12; while patients in the lower dosing arm demonstrated statistically significant improvement at weeks eight and 12 compared to placebo.
About the Study
The study, conducted at 19 sites in the United States, was designed as a double-blind, placebo-controlled trial with three treatment groups (0.3 mg SCE-B, n= 53; 0.625 mg SCE-B, n=52; or matching placebo, n=52).
All participants were naturally or surgically postmenopausal women, with or without a hysterectomy, aged 30 to 65 years. In order to be accepted into the study, each participant, during a minimum qualification period of two weeks, must have experienced on average at least seven daily (or 50 weekly) moderate-to-severe hot flashes, and at least three disruptions per night due to hot flashes over seven consecutive days.
Over the course of the study, patients were evaluated during clinic visits at weeks two, four, eight and 12, during which time frequency of nighttime hot flashes was recorded in daily written diaries. Each participant was asked to record the time the pills were taken, as well as the number of "sleep time" awakenings they attributed to hot flashes.
Menopause is the time in a woman's life when the menstrual period ceases and the ovaries permanently stop releasing eggs. Menopause is considered complete when a woman has been without her period for a full year. While some women experience no menopausal symptoms, others suffer severe symptoms that may require treatment. Vasomotor symptoms (hot flashes and night sweats) and vaginal atrophy are the most common menopausal symptoms. Although the majority of women experience "natural" or spontaneous menopause, some women may experience menopause due to a medical intervention such as surgery, chemotherapy or radiation. For more information about menopause, please visit www.CopeWithMenopause.com.
Important Safety Information about ENJUVIA® (synthetic conjugated estrogens, B)
Important health information you should know when taking estrogens like ENJUVIA: Estrogens increase the risk for cancer of the uterus (womb). If you experience persistent or recurring vaginal bleeding while taking estrogens let your doctor know right away, as this could be a warning sign for cancer. Your doctor should check for the cause of any unusual vaginal bleeding after menopause.
Estrogens (alone, or in combination with progestins) should not be used to prevent heart disease, heart attacks, strokes, or dementia.
Estrogens (alone or in combination with progestins) may increase the risk of heart attack, stroke, blood clots, and breast cancer. Estrogens (alone or in combination with progestins) may increase your risk of dementia, based on a study of women age 65 or older. Because of these risks, estrogens should be used at the lowest dose for the shortest period of time. You and your doctor should talk regularly to determine whether you still need treatment with ENJUVIA.
Who should not use ENJUVIA?
Do not use ENJUVIA if you:
What are the common side effects with ENJUVIA?
You may experience headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating, nausea and vomiting, or hair loss.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Women and healthcare providers who would like to learn more about ENJUVIA, including full prescribing information, should visit www.ENJUVIA.com.
About Teva Women's Health, Inc.
Teva Women's Health, Inc., (formerly Duramed Pharmaceuticals, Inc.) which develops and markets proprietary pharmaceutical products in North America, focuses primarily on products for women and emphasizes the development and marketing of products for reproductive and menopausal needs.
Teva Women's Health, Inc., is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA), headquartered in Israel, is among the top 15 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Neurontin®, Lotrel® and Protonix®, the extent to which any manufacturing or quality control problems damage our reputation for high quality production, the effects of competition on sales of our innovative products, especially Copaxone® (including potential generic and oral competition for Copaxone®), the impact of continuing consolidation of our distributors and customers, our ability to identify, consummate and successfully integrate acquisitions, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, intense competition in our specialty pharmaceutical businesses, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation, adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, dependence on the effectiveness of our patents and other protections for innovative products, our ability to achieve expected results through our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, uncertainties surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, our potential exposure to product liability claims to the extent not covered by insurance, the termination or expiration of governmental programs or tax benefits, current economic conditions, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").
-- May be pregnant -- Have had a stroke or heart attack in the past year -- Have unusual vaginal bleeding -- Are allergic to ENJUVIA or any of its ingredients -- Have a history of certain cancers, blood clots, or liver problems
SOURCE Teva Women's Health, Inc.