ROCHESTER, N.Y., Oct. 19 /PRNewswire/ -- PharmaNova, Inc. announced today that it has exclusively licensed certain U.S. patent rights to Depomed, Inc. to develop and commercialize an extended release formulation of gabapentin as a non-hormonal alternative treatment for hot flashes and other vasomotor symptoms of menopause. In exchange for these rights, Depomed agreed to pay PharmaNova an upfront licensing fee, milestone fees and royalties on product sales.
"We are delighted to partner our lead women's health project with Depomed," said Rodney Brown, president of PharmaNova. "Depomed's excellent work to date with Gabapentin GR to treat neurological pain may allow us to leverage data already generated. The market for hot flashes is sizeable and characterized by a significant unmet need because women and their doctors have increasingly shied away from traditional HRT (hormone replacement therapy). A long-acting formulation of gabapentin may prove in clinical trials to be a safer, effective alternative to HRT in the treatment of hot flashes."
This innovative product development results from Dr. Thomas Guttuso's clinical research at the University of Rochester demonstrating that gabapentin is effective in treating hot flashes of menopause, and subsequent studies by Dr. Sireesha Reddy and co-workers demonstrating gabapentin to be as effective as estrogen in treating hot flashes.
Approximately 70 percent of North American women have hot flashes at some level of intensity during menopause. Hot flashes are sudden waves of heat that can start in the waist or chest and work their way to the neck and face and sometimes over the rest of the body. They are characterized by a sudden temporary onset of body warmth, flushing and sweating. Depending on the intensity of the hot flash, some women may experience headaches, fatigue, dizziness, or heart palpitations. The principal government-approved prescription products in the United States for treating this menopause-related symptom are estrogen or estrogen/progestin combinations (HRT), which have been associated with increased risk of breast cancer, coronary heart disease, thromboembolism, stroke and dementia.
The use of estrogen for treating hot flashes was challenged when results of an NIH-sponsored Women's Health Initiative trial were published in the July 2002 issue of JAMA, demonstrating that HRT significantly increased risk of coronary heart disease and stroke. The results of this trial caused the $2 billion hormone replacement market to decline by over $800 million in just over six months, representing a loss of over 34 million prescriptions.
PharmaNova, Inc. is a specialty drug development company based in Rochester, NY, founded on the re-engineering of known drugs using proprietary Medisperse(TM) nanoparticle and other formulation technologies. PharmaNova's current focus is on clinically important high-value products in Women's Health, anti-viral agents and cancer chemotherapeutics. PharmaNova, Inc. is seeking additional development and commercial partners for these important technologies and product candidates in the U.S. and other markets worldwide.
Rodney A. Brown
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