FDA approves Berlex's Climara Pro hormone patch to prevent postmenopausal osteoporosis

By E. Janene Geiss

Philadelphia, Jan. 4 - Berlex, Inc. announced Wednesday that the Food and Drug Administration has approved the hormone therapy patch Climara Pro (estradiol/levonorgestrel transdermal system) for the prevention of postmenopausal osteoporosis.

Climara Pro was approved by the FDA in November 2003 as a treatment for moderate to severe vasomotor symptoms such as hot flashes and night sweats associated with menopause. Now Climara Pro is the only combination once-a-week hormone therapy patch approved for the prevention of postmenopausal osteoporosis and the relief of vasomotor symptoms associated with menopause, according to a company news release.

"While it has long been accepted that estrogen 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," Paul Korner, executive director of medical affairs for female health care at Berlex, said in the release.

The transdermal technology of Climara Pro allows for weeklong continuous delivery of the hormones estradiol (0.045 mg a day), the same estrogen made by the ovaries prior to menopause and levonorgestrel (0.015 mg a day), which helps protect the endometrium, officials said.

Climara Pro delivers the hormones through a thin, translucent patch that is affixed to the skin and virtually invisible after being applied, officials said.

With the addition of levonorgestrel, Climara Pro is indicated for use by women with an intact uterus, whereas Climara is appropriate for women who have had a hysterectomy, officials said.

Two well-controlled, randomized clinical trials showed that Climara Pro effectively controlled menopausal symptoms. For many patients, the frequency and severity of hot flashes was significantly reduced as early as week one, and 90% of women experienced an 80% reduction in hot-flash frequency by week 12, officials said.

It has an acceptable side effect profile, officials said. Clinical trial participants using Climara Pro also experienced a low skin irritation rate, no effect on body weight and a bleeding profile comparable to other combination hormone therapies, officials said.

Based in Wayne, N.J., Berlex, a U.S. affiliate of Schering AG of Germany, is committed to addressing unmet medical needs through research and development in the areas of oncology, gastroenterology, women's health, diagnostics and neurology.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.