Duramed's ENJUVIA Tablets Receives Two New FDA Approvals
Duramed Pharmaceuticals announced that the Company has received two U.S. Food and Drug Administration approvals related to its ENJUVIA (synthetic conjugated estrogens, B) product.
The FDA has approved the Company's supplemental New Drug Application (sNDA) for 0.9 mg tablet strength, which will be added to the Company's existing ENJUVIA product line that includes the 0.3 mg, 0.45 mg, 0.625 mg, and 1.25 mg tablet dosage strengths.
In addition, ENJUVIA is also the first and only oral estrogen that has been approved by FDA to treat moderate-to-severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. When prescribing for the treatment of moderate-to-severe vaginal dryness and pain with intercourse, topical vaginal products should be considered. ENJUVIA is already indicated for the treatment of moderate-to- severe vasomotor symptoms associated with menopause.
"The approval of the 0.9 mg tablet further expands the ENJUVIA line and will provide healthcare professionals with additional dosing flexibility for their patients using oral estrogen therapy," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "The approval of the additional indication for ENJUVIA provides female healthcare providers with yet another option for addressing symptoms associated with menopause and may make ENJUVIA an appropriate therapeutic option for a larger group of menopausal patients. Both approvals expand the value of the ENJUVIA therapy option for health care providers and patients and our Women's Health Sales Force will be detailing the additional strength and expanded indication."
The Company plans to launch the ENJUVIA 0.9 mg tablet and the new indication for the ENJUVIA product line in October 2007 at the North American Menopausal Society Annual Meeting. Duramed currently promotes ENJUVIA to healthcare providers using its 250-person Women's Healthcare Sales Force.
Duramed's ENJUVIA is a plant-derived formulation, ENJUVIA contains a blend of 10 synthetic estrogenic substances including delta 8,9 - dehydroesterone sulfate (DHES). ENJUVIA uses a unique delivery system, consisting of Surelease(R) technology with a cellulose-based polymer tablet design, to provide slow release of estrogens over several hours.
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 require treatment. Vasomotor symptoms (night sweats, hot flashes, vaginal dryness) 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.
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.
The estrogen alone substudy of Women's Health Initiative (WHI) study reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) relative to placebo.
The estrogen-plus-progestin substudy of the WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral CE 0.625 mg combined with medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo.
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.