ElestrinTreatment for Postmenopausal Symptoms
BioSante Pharmaceuticals Announces Bio-E-Gel NDA Submission
LINCOLNSHIRE, Ill., February 16, 2006 - BioSante Pharmaceuticals, Inc. (Amex:BPA) announced today it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Bio-E-Gel (transdermal estradiol gel) to treat moderate-to-severe hot flashes in menopausal women.
The NDA includes data from one pivotal Phase III clinical trial of Bio-E-Gel and data from three additional clinical trials required by the FDA, including a transfer study, a sunscreen study and a pharmacokinetic study.
The Phase III trial was a 12-week, randomized, double-blind, placebo-controlled study of 484 symptomatic menopausal women. Following FDA recommendations, the Phase III trial tested three doses of Bio-E-Gel in order to establish the lowest effective dose and maximize the safety profile. The four co-primary endpoints, as defined by the FDA, are a significant decrease over placebo in both the number and severity of hot flashes at Week 4 and Week 12 of treatment.
Across the low, mid, and high Bio-E-Gel doses tested in the Phase III trial, there was a clear dose response in the reduction in the number and severity of hot flashes.
By Week 4 of treatment, the mid and high doses of Bio-E-Gel showed highly significant decreases in the number and severity of hot flashes versus placebo (p less than 0.0001), and this significant response was maintained from Week 4 to Week 12 of treatment (p less than 0.0001).
Beginning at Week 5, the low dose of Bio-E-Gel showed a highly significant decrease in the number (p less than 0.001) and severity (p less than 0.01) of hot flashes versus placebo, therefore suggesting identification of the lowest effective dose. This significant response for both number and severity of hot flashes was maintained through Week 12 (p less than 0.0001). Importantly, over 80 percent of women who used Bio-E-Gel reported "moderate" or "great" results with Bio-E-Gel (p less than 0.0001). The company in its NDA is seeking approval for all three doses.
There were no significant differences in the safety profile of any dose of Bio-E-Gel compared to placebo other than for predictable estrogen effects such as breast tenderness.
"We are very pleased to have submitted the Bio-E-Gel NDA. Bio-E-Gel Phase III trial results indicate the lowest effective dose of Bio-E-Gel thereby establishing the safest dose of Bio-E-Gel for women to reduce hot flashes. We believe the low dose of Bio-E-Gel shown to be safe and effective in this trial also may be the lowest dose of estrogen available on the market to treat hot flashes, if and when approved, and will be an attractive alternative to currently marketed estrogen therapies," said Stephen M. Simes, president and CEO of BioSante. "We believe Bio-E-Gel if and when approved by the FDA will be well positioned to compete in the U.S. estrogen therapy market, currently estimated to total approximately $1.4 billion in annual sales."
Bio-E-Gel is a gel formulation of estradiol (the same estrogen made by women) designed to be quickly absorbed through the skin after topical application on the arm and shoulder delivering estradiol to the bloodstream evenly over time at minimal dosage and in a non-invasive, painless manner.
Estrogen products today are approved for the treatment of menopausal symptoms, including hot flashes. Estrogen products are not approved for and should not be used for the treatment or prevention of heart disease or dementia. The 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 of treatment with oral conjugated equine estrogens (CEE 0.625 mg) alone per day, relative to placebo. The WHI study reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated equine estrogens (CEE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day.
Posted: February 2006
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