FLORHAM PARK, N.J.–(BUSINESS WIRE)– Shionogi Inc., a global leader dedicated to women’s health, will unveil four abstracts containing new analyses and safety and efficacy data from clinical trials of ospemifene (available in the U.S. marketplace as Osphena®) at the 25th Annual Meeting of The North American Menopause Society (NAMS) in Washington, DC on October 15-18, 2014. Osphena® (ospemifene) is approved for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Following are the abstracts being presented on Osphena during the NAMS annual conference:
Title: Ospemifene Improved The Severity of Vulvar and Vaginal Atrophy Symptoms In Postmenopausal Women in Phase 3 Randomized, Placebo-Controlled Trials1
Author: Oral presentation by Ginger Constantine
Presentation date/time: Concurrent Session #1 Friday, Oct 17, 5:00-5:15PM
Title: Responder Analysis of Ospemifene Treatment for Vulvar and Vaginal Atrophy in Postmenopausal women in Phase 3 Randomized, Placebo-Controlled Trials2
Author: Oral presentation by Risa Kagan
Presentation date/time: Concurrent Session #1 Friday, Oct 17, 5:15-5:30PM
Title: Improvement in Female Sexual Function by Ospemifene Treatment Is Not Associated with Changes in Serum Hormones in Postmenopausal Women with Vulvar and Vaginal Atrophy3
Author: Oral presentation by Dr. Sheryl Kingsberg
Presentation date/time: Concurrent Session #2 Thursday, Oct 16, 4:45-5:00PM
Title: Effect of Ospemifene on Vasomotor Symptoms in Postmenopausal Women4
Author: Poster presentation by JoAnn Pinkerton
Presentation date/time: Poster Session Thursday, Oct 16, 6:00-7:00 PM
A full list of the abstracts being presented at NAMS will be available online at www.menopause.org on October 15, 2014.
For more information on Osphena® (ospemifene) please visit www.osphena.com.
Serious risks of estrogen-alone therapy or Osphena® can include increased risk of endometrial cancer, stroke, and deep vein thrombosis (DVT). Osphena should be prescribed for the shortest duration consistent with treatment goals for the individual woman. Women considering treatment for moderate to severe dyspareunia are encouraged to discuss the potential risks and benefits of Osphena® with their healthcare provider.
Osphena® (ospemifene) is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Important Safety Information for Osphena
- Undiagnosed abnormal genital bleeding
- Known or suspected estrogen-dependent neoplasia
- Active deep vein thrombosis (DVT), pulmonary embolism (PE) or a history of these conditions
- Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions
- Women who are or may become pregnant. Osphena may cause fetal harm when administered to a pregnant woman. Ospemifene was embryo-fetal lethal with labor difficulties and increased pup deaths in rats at doses below clinical exposures, and embryo-fetal lethal in rabbits at 10 times the clinical exposure based on mg/m2. If this drug is used during pregnancy, or if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus.
Warnings and Precautions
In Osphena clinical trials of up to 15 months the incidence rates compared to placebo for thromboembolic and hemorrhagic stroke were 0.72 Osphena 60 mg vs. 1.04 placebo and 1.45 Osphena 60 mg vs. 0 placebo per thousand women. Should thromboembolic or hemorrhagic stroke occur or be suspected, Osphena should be discontinued immediately. In clinical trials, a single MI occurred in a woman receiving Osphena 60 mg.
Incidence rate of DVT was 1.45 Osphena vs. 1.04 placebo per thousand women. Should a VTE occur or be suspected, Osphena should be discontinued immediately. Osphena should be discontinued at least 4 to 6 weeks before surgery with increased risk of thromboembolism or during periods of prolonged immobilization.
There is an increased risk of endometrial cancer in a woman with a uterus who use unopposed estrogen therapy. The risk appears dependent on duration of treatment and estrogen dose. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. However, studies suggest a possible increased risk for breast cancer in patients receiving estrogen plus progestin therapy.
Osphena is an estrogen agonist/antagonist with tissue selective effects. In the endometrium Osphena has agonistic effects. In Osphena clinical trials, no cases of endometrial cancer were seen with exposure up to 52 weeks. There was a single case of simple hyperplasia without atypia. Endometrial thickening equal to 5mm or greater was reported at a rate of 60.1 Osphena vs. 21.2 placebo per 1000 women. Uterine polyps occurred at an incidence of 5.9 Osphena vs. 1.8 placebo per 1000 women, and any type of proliferative endometrium (weakly plus active plus disordered) was 86.1 Osphena vs. 13.3 placebo per 1000 women.
Osphena has not been adequately studied in women with breast cancer; therefore it should not be used in women with known or suspected breast cancer or with a history of breast cancer.
Osphena should not be used in women with severe hepatic impairment as it has not been studied.
In clinical trials the more commonly reported adverse reactions in ≥1 percent of patients treated with Osphena 60 mg compared to placebo were: hot flush (7.5% vs. 2.6%), vaginal discharge (3.8% vs. 0.3%), muscle spasms (3.2% vs. 0.9%), hyperhidrosis (1.6% vs. 0.6%), and genital discharge (1.3% vs. 0.1%).
Drug interactions: Do not use estrogens or estrogen agonists/antagonists, fluconazole, or rifampin concomitantly with Osphena. Co-administration of Osphena with drugs that inhibit CYP3A4 and CYP2C9 may increase the risk of Osphena related adverse reactions. Osphena is highly protein bound. Use cautiously with highly protein bound drugs as use with other highly protein-bound drugs may lead to increase exposure of that drug or ospemifene.
Please read accompanying US Full Prescribing Information for Osphena® (ospemifene) tablets, including Boxed WARNING, and Patient Information
Shionogi Inc. is the U.S.-based subsidiary of Shionogi & Co., Ltd., a Japanese pharmaceutical company with a distinguished 135-year history of discovery and development of innovative therapies. Shionogi Inc. continues this focus on the development and commercialization of high quality medicines to meet patient needs, while recognizing and addressing the highly personal nature of healthcare. In the U.S., Shionogi Inc. is primarily focused on two therapeutic areas, women’s health and pain. Pipeline products are in the areas of allergy, oncology, anti-infectives, and endocrinology. For more details, please visit www.shionogi.com. For more information on Shionogi & Co., Ltd., please visit www.shionogi.co.jp.
1 Constantine GD, Goldstein SR, Archer DF. Endometrial safety of ospemifene: results of the phase 2/3 clinical development program.
2 Kagan R, Portman DJ, Archer DF, et al. Responder Analysis of Ospemifene Treatment for Vulvar and Vaginal Atrophy in Postmenopausal Women in Phase 3 Randomized, Placebo-Controlled Trials.
3 Kingsberg S, Graham S, Rosen R, et al. Improvement in Female Sexual Function by Ospemifene Treatment Is Not Associated with Changes in Serum Hormones in Postmenopausal Women with Vulvar and Vaginal Atrophy.
4 Pinkerton J, Archer DF, Graham S, et al. Effect of Ospemifene on Vasomotor Symptoms in Postmenopausal Women.