December 20, 2007
Femarelle drug treats menopause onset osteoporosis sans hormones
The connection between menopause and osteoporosis is well-documented. At the onset of menopause, following the decrease of estrogen in the body, the bone undergoes a yearly decline of bone mass density (BMD) of 2 percent to 3 percent a year in the first seven years following menopause. This leads to the development of osteoporosis, which affects 50 percent of postmenopausal women today.
Slowing the process of bone loss, while alleviating menopausal symptoms, requires a therapy that targets the physiological mechanisms affected by estrogen. And the general treatment prescribed by doctors has traditionally been hormone therapy.
However, a consensus is growing throughout the medical world regarding the increased risk of blood clotting for women taking hormones. Fifteen percent to 20 percent of women have a genetic history of blood clotting, and many recent studies point to increased health risks associated with hormone therapy.
"Unfortunately, hormone therapy has risky side effects for some women," said Dr. Israel Yoles, an Israeli gynecological expert who practices at the Sheba Medical Center and runs the Ashdod Center for Women's Health. "Hormones increase the risk of clot formations, which can lead to stroke."
As one in five women are exposed to such life-threatening risks, physicians have faced a major dilemma regarding how to manage the symptoms associated with the onset of menopause.
"The medical community is anxious to find a solution, which can fight the acute symptoms of menopause without increasing chances of blood clotting," said Yoles, who is also the medical director of Se-cure Pharmaceuticals Ltd., a company that has developed a dietary supplement that it believes could be the solution.
Se-cure's flagship product, Femarelle, was launched in 1999 and is now available in 15 countries, including the United States. It is derived through a unique enzymatic procedure that creates a specific biochemical composition proven to combine the treatment of menopausal symptom relief and bone loss.
"Femarelle activates the estrogen to relieve menopausal symptoms and help prevent osteoporosis, but it won't activate the estrogen where it's not wanted, like in the breasts or the uterus," Yoles said.
He explained that for such a therapy to be safe, it must be selective -- affecting estrogen receptors only in specific sites without affecting tissues where any change can have dangerous consequences. Which is exactly what Femarelle does -- acting as a novel selective estrogen receptor modulator (SERM) drug.
"The idea behind the category of SERM drugs was to produce a compound which acts selectively in activating estrogen in various parts of the body," Yoles said.
Femarelle has been proven in clinical studies to exert stimulatory activity on the estrogen receptors that control menopausal symptoms and the process of bone buildup, while having a blocking effect on estrogen receptors in the breast and the uterus. Moreover, Femarelle was shown to have a unique mechanism of action on bone buildup through increased osteoblast activity, having a direct effect on bone formation.
"We've shown it's efficacy and safety in numerous clinical trials and can now say that Femeralle effectively treats menopausal symptoms and elevates bone mass density, but at the same time selectively delivering the estrogen to the body," Soles said.
In October, findings of the effectiveness of Femarelle were presented to the international medical community at the seventh Congress of the European Society of Gynecology in Paris by Dr. Lila Nachtigall, former president of the North American Menopause Society (NAMS) and director of the Women's Health Center at New York University.
"She's well known around the world for her work in menopause studies," Soles said. "Her studies have shown that women who displayed no clotting problems responded to oral estrogen fine. But women with borderline clotting signs had accelerated clotting signs after taking the estrogen. The tendency to produce clots is aggravated due to taking oral estrogen."
However, Nachtigall's recent study on Femeralle, which was presented in Paris, showed that when given the drug instead of oral estrogen, the women with borderline signs showed no increased clotting signs.
"People who heard the presentation in Paris were very excited about the results," said Yoles, who attended the meeting with Nachtigall. "And just as importantly as the results on its efficiency, the study showed that Femarelle was safe."
That point is of utmost concern for both Yoles and Se-cure CEO Ron Gutterman, who founded the company in 1997.
"The new generation treatments need to show evidence of more than therapeutic relief; proof that the risks do not outweigh the benefits of treatment is at the forefront of consumer concern," said Gutterman. "The new age drugs are expected to integrate treatment of the different mechanisms involved in illness and to target the cause of an illness, rather than only its symptoms. The successful development of Femarelle has cemented this concept."
"What we're saying, ultimately, is that if a doctor prescribes hormone therapy, then fine," Yoles said. "But there is growing concern among both doctors and women who are hesitant to take the hormone treatment. So try Femarelle as first line of treatment. It's been proven to be safe and effective."
David Brinn is editor of ISRAEL21c, a media organization focusing on 21st century Israel.
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