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Posted 04/07/03, by Amanda Weatherman
Gel that delivers hormones treats disease's major symptoms
Fibromyalgia affects between 3 and 6 million Americans, or 1–2 percent of the nation's population, mostly women, according to government statistics. Its symptoms are typically widespread muscle pain and extreme fatigue, among others. Its cause is unknown, and an effective treatment has not yet been developed. But Dartmouth researcher Hillary White has created a gel that delivers androgen hormones through the skin, and early trials have shown it to be effective in treating the major symptoms of fibromyalgia.
"We are excited about our initial success with low-dose androgen therapy in a group of fibromyalgia patients," said White, Associate Professor of Microbiology and Immunology at Dartmouth Medical School. "From our initial study, made possible by the Technology Transfer Office, we now know appropriate doses of androgen that can be delivered to patients transdermally [through the skin]."
Fibromyalgia usually strikes women between the ages of 44 and 53, and has been estimated to affect 2–5 percent of postmenopausal and perimenopausal women. Some estimates say the range could be from 0.5 to 20 percent. White said that previously, no treatment was effective against the disease's symptoms, which can be debilitating, but the androgen therapy she's developing appears to reduce the primary symptoms of pain and chronic fatigue. Delivering the hormones through the skin is the critical part of the treatment developed by White.
"Transdermal delivery allows for long-lasting delivery over a 24-hour time period," she said. "Slow delivery is especially important for non-derivatized sex-steroid hormones, since they are typically degraded with a short half-life of 10–100 minutes. If the positive responses we have seen so far are confirmed in larger trials, it will indicate that androgen replacement therapy is important for decreasing the hypersensitivity to pain and chronic fatigue that fibromyalgia patients experience."
Bentley Pharmaceuticals, Inc. in North Hampton, N.H., purchased a license from Dartmouth for exclusive rights to manufacture and distribute the gel on the market. Bentley already has a proprietary technology for delivering medications through the skin. Staff members at Dartmouth's Technology Transfer Office saw the company as ideal for developing the treatment. They approached Bentley with the idea, and it struck a chord with Bentley Vice President of Pharmaceutical Development Bob Gyurik.
"Our license from Dartmouth allows us to combine androgens with Bentley's drug delivery technology," Gyurik said. "We hope that this therapy will soon become available for women afflicted by this debilitating disease."
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