Bradley Pharmaceuticals Inc. has announced that its partner, BioSante Pharmaceuticals was issued a new formulation patent for Elestrin (estradiol gel 0.06%). Elestrin was approved in December 2006 by the FDA for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. This new formulation patent covers gel formulations into 2022.
Bradley has exclusive marketing rights for Elestrin in the US and expects to launch the product through its Kenwood Therapeutics division in June 2007.
"Elestrin will offer the lowest effective dose of estradiol approved by FDA for the treatment of moderate to severe vasomotor symptoms. This dosage is a 50 per cent lower daily dose than the next lowest competitive dose of estradiol," stated Daniel Glassman, president and CEO of Bradley Pharmaceuticals. "We believe that Elestrin will provide physicians with an important treatment option for patients who suffer from and choose to manage their menopausal symptoms."
"An important part of Bradley's strategic plan is to in-license phase II and phase III drugs with long-term intellectual property protection, develop these products and bring to market brands that fill unmet patient needs. The additional patent on Elestrin demonstrates Bradley's ability to effectively target new therapies with long-term intellectual property protection," added Glassman.
Elestrin is indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures should be undertaken to rule out malignancy in cases of undiagnosed, persistent or recurring abnormal vaginal bleeding.
Long-term continuous administration of estrogen, with or without progestin, has shown an increased risk of endometrial, breast and ovarian cancers.
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older was reported with estrogen-alone use, as well as, in combination with progestin.
Estrogen-alone therapy has been associated with an increased risk of stroke and deep vein thrombosis. Estrogen plus progestin therapy has been associated with an increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis. Estrogens should be discontinued immediately if any of these events occur or are suspected.
Estrogen with or without progestin should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the patient.
An increase in gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported. Estrogen therapy may lead to severe hypocalcaemia in patients with breast cancer and bone metastases. Retinal vascular thrombosis has been reported in patients receiving estrogens.
Estrogen products should not be used in women with undiagnosed abnormal genital bleeding; known, suspected or history of breast cancer; known or suspected estrogen-dependent neoplasia; active or history of deep vein thrombosis or pulmonary embolism; active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction); liver dysfunction or disease; known or suspected pregnancy.