FDA Approved Treatment for Painful Intercourse (Dyspareunia) Due to Menopause

The United States (U.S.) Food and Drug Administration (FDA) has approved Osphena™ (ospemifene) tablets, Shionogi Inc.’s treatment for moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. VVA is a chronic and progressive condition caused by decreased estrogen due to menopause in women.

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Florham Park, NJ (PRWEB) February 27, 2013

The United States (U.S.) Food and Drug Administration (FDA) has approved Osphena™ (ospemifene) tablets, Shionogi Inc.’s treatment for moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. VVA is a chronic and progressive condition caused by decreased estrogen due to menopause in women.

Dyspareunia is one of the most common symptoms of VVA. Although approximately 32 million postmenopausal U.S. women experience the signs and symptoms of VVA, up to 70 percent of women who live with symptoms remain undiagnosed because many are not proactively addressing the condition with their healthcare professionals (HCPs).

Many women do not associate VVA with menopause and, because it is not a topic that is frequently discussed, they are unaware of how common this condition is among postmenopausal women. As a result, the symptoms of VVA, such as dyspareunia, are often unanticipated and may go untreated. However, while many symptoms of menopause, such as hot flashes or flushes, lessen or disappear with time, VVA usually persists and may even worsen without treatment.

“Women tend to accept dyspareunia as part of getting older, but they do not have to live in silence with the condition,” said David J. Portman, M.D., OB/GYN, Director of the Columbus Center for Women’s Health Research. “As a convenient once-daily oral medication, Osphena is an important treatment alternative for millions of women living with painful intercourse due to menopause.”

Prescription therapy is often required for symptomatic women. Osphena, as an estrogen agonist/antagonist with tissue selective effects, is the first and only oral treatment alternative to vaginal or oral estrogens for women with dyspareunia due to menopause. Osphena demonstrated significant improvements in painful intercourse as well as on the physical changes of the vagina associated with menopause.

Osphena is an estrogen agonist/antagonist with tissue selective effects. 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 dyspareunia are encouraged to discuss the potential risks and benefits of Osphena with their healthcare provider. Please see below for additional Important Safety Information.

For more information about dyspareunia, VVA and Osphena, please visit http://www.WhatIsDyspareunia.com.

Important safety information for osphena™ (ospemifene) tablets:

Boxed warning: endometrial cancer and cardiovascular disorders

Osphena is an estrogen agonist/antagonist with tissue selective effects. In the endometrium osphena has estrogen agonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogen therapy. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

The women’s health initiative (WHI) estrogen-alone substudy reported an increased risk of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg], relative to placebo. Osphena 60 mg had cerebral thromboembolic and hemorrhagic stroke incidence rates of 0.72 and 1.45 per thousand women vs. 1.04 and 0 per thousand women for placebo and a DVT incidence rate of 1.45 vs. 1.04 per thousand women for placebo. Osphena should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.

Contraindications

  •     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
  •     In women who are or may become pregnant, as Osphena may cause fetal harm

Warnings and Precautions

Cardiovascular Disorders: In the WHI estrogen-alone substudy, a statistically significant increased risk of stroke was reported in postmenopausal women (50 to 79 years of age) receiving CE 0.625 mg per day relative to placebo (45 vs. 33 per 10,000 women-years). The increase in risk was demonstrated in year 1 and persisted. In Osphena clinical trials of up to 15 months the incidence rates compared to placebo for cerebral 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.

Coronary Heart Disease: In the WHI estrogen-alone substudy, no overall effect on coronary heart disease (CHD) events (defined as nonfatal MI, silent MI, or CHD death) was reported in women receiving estrogen-alone compared to placebo. In clinical trials, a single MI occurred in a woman receiving Osphena 60 mg.

Venous Thromboembolism: In the WHI estrogen-alone substudy, the risk of VTE (DVT and PE) was increased for women receiving CE 0.625 mg alone compared to placebo (30 vs. 22 per 10,000 women-years), although only increased risk of DVT reached statistical significance (23 vs. 15 per 10,000 women- years). The increase in VTE risk was demonstrated during the first 2 years. 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.

Malignant Neoplasms

Endometrial Cancer: There is an increased risk of endometrial cancer in a woman with a uterus who uses 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.
  •     Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

Breast Cancer: Osphena has not been adequately studied in women with breast cancer; therefore Osphena should not be used in women with known or suspected breast cancer or with a history of breast cancer.

Severe Hepatic Impairment: Do not use Osphena in women with severe hepatic impairment as it has not been studied.

Adverse Reactions: In clinical studies, the more commonly reported adverse reactions (greater than or equal to 1 percent) in patients treated with Osphena 60 mg compared to placebo were: hot flush (7.5 percent vs. 2.6 percent), vaginal discharge (3.8 percent vs. 0.3 percent), muscle spasms (3.2 percent vs. 0.9 percent), hyperhidrosis (1.6 percent vs. 0.6 percent), and genital discharge (1.3 percent vs. 0.1 percent).

Drug Interactions

  •     Do not use estrogens or estrogen agonists/antagonists or fluconazole concomitantly with Osphena.
  •     Moderate to Strong CYP3A4 inhibitors (e.g., ketoconazole, fluconazole) will increase Osphena (ospemifene) drug concentrations while moderate to strong CYP3A4, CYP2C9, or CYP2C19 inducers (e.g. rifampin) will decrease Osphena (ospemifene) drug concentrations.
  •     Coadministration of Osphena with drugs that inhibit CYP3A4 and CYP2C9 may increase the risk of Osphena related adverse reactions.
  •     Osphena had no effect on the pharmacokinetics of a single 10 mg dose of warfarin. The effect of Osphena on International Normalized Ration (INR) or prothrombin time (PT) was not studied.
  •     Osphena (ospemifene) 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.

Click here for the U.S. Full Prescribing Information for Osphena (ospemifene) tablets, including Boxed WARNING and Patient Information. For more information, please visit http://www.Osphena.com.

Indications and Usage for Osphena™ (ospemifene) tablets

Osphena™ (ospemifene) is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

About Shionogi
Shionogi Inc. is the U.S.-based subsidiary of Shionogi & Co., Ltd., headquartered in Osaka, Japan. Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi’s research and development currently targets three therapeutic areas: infectious diseases, pain, and metabolic syndrome. In addition, Shionogi is engaged in new research areas such as allergy and cancer. Contributing to the health of patients around the world through development in these therapeutic areas is Shionogi’s primary goal. For more details, please visit http://www.shionogi.co.jp. For more information on Shionogi Inc., headquartered in Florham Park, NJ, please visit http://www.shionogi.com.

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Contact

  • Renee Lippman
    Shionogi Inc.
    973-307-3877
    Email
  • Amy Losak
    Ketchum
    646-935-3917
    Email

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