Schering AG of Germany said yesterday its US subsidiary Berlex Laboratories has won approval for Climara Pro, a patch delivering hormone therapy, for the prevention of post-menopausal osteoporosis.
The new indication for Climara Pro (estradiol/levonorgestrel), which was first approved in the USA in November 2003 as a treatment for moderate-to-severe vasomotor symptoms associated with menopause, makes it the combination once-a-week hormone therapy patch approved for both these indications.
Schering has high hopes for the product in the osteoporosis indication, despite the negative publicity surrounding hormonal therapies for prevention of the diseases. In 2003, the results of the Women's Health Initiative trial showed that oral combination hormonal treatment with Wyeth’s Prempro was associated with a greater risk of breast cancer, stroke and heart, findings that were replicated in the UK's Million Women Study.
Sales of hormone replacement therapies slumped after regulatory authorities around the world slapped warnings on the products. But with the market blown wide open, transdermal hormone products, which deliver a much lower dose of hormone, could benefit.
"While it has long been accepted that oestrogen helps maintain bone density following menopause, our studies, and this new indication, solidify the positive effect that Climara Pro has on bones, while helping women manage moderate to severe vasomotor symptoms associated with menopause," said Paul Korner, director of medical affairs for female healthcare at Berlex.