Berlex Laboratories announced the new drug application (NDA) seeking approval for a transdermal estrogen therapy for the prevention of osteoporosis, delivering 0.014 mg of estradiol each day, has been accepted for filing by the U.S. Food and Drug Administration (FDA).

This patch, under the proposed name Menostar, delivers nearly 50 percent less estrogen per day than the lowest dose transdermal estrogen product currently available for the prevention of osteoporosis. Upon approval, Menostar will offer healthcare providers with a new treatment option that delivers an ultra-low dose of plant-based estrogen, which will not require a concomitant progestin, even for women with an intact uterus.

"Osteoporosis is a pervasive and debilitating disease, and women and healthcare providers are seeking lower dose therapy that can help preserve bone," said Marie Foegh, Vice President, Medical Affairs for Berlex Laboratories. "We are particularly excited about the dramatic new approach of moving estrogen therapy toward the lowest effective level for bone without needing a progestin."

The NDA is based on data from a two-year, randomized, multi-center, placebo-controlled clinical trial sponsored by Berlex. The once-a-week patch studied, only 3.25 cm in size, was developed using 3M transdermal technology. In the clinical trials, Menostar was well tolerated; the most common side effects were application site irritation and leukorrhea.

Osteoporosis is the second most prevalent health issue faced by postmenopausal women. Approximately 8 million women in the US suffer from osteoporosis and about 27 million women have a bone mineral density deficiency. Low bone density places women at risk for fractures that often require major surgery and hospitalization and can cause prolonged disability or even death. Women are also four times more likely to develop osteoporosis than men. The National Osteoporosis Foundation estimates that direct medical costs associated with osteoporosis is $17 billion per year.