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Sarfez completes trial of novel extended-release diuretic

Tuesday, November 12, 2013 Clinical Trials News
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Sarfez Pharmaceuticals has completed a trial of its novel loop diuretic drug that has the potential to revolutionize the quality of life and life expectancy of patients suffering from chronic kidney disease, congestive heart failure and resistant hypertension.
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By adapting an existing drug—Torsemide— into a much-needed extended release formulation, Sarfez is hoping to give patients resistant to the current diuretics a drug that will support their diuresis for more than 12 hours, rather than the maximum of four hours available with current medications. The company's formula also preserves a patient's potassium levels, making this the first drug of its kind to successfully protect this electrolyte essential for nerve and muscle function.
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"I see patients every day who are in desperate need of another option to treat their excessive fluid accumulation in chronic kidney disease and congestive heart failure. The drugs on the market today, while helpful, still put these patients on a roller coaster of side effects and symptoms and do little to impact their disease," said Christopher Wilcox, Ph.D., M.D., chief of nephrology and hypertension at Georgetown University Medical Center. "Torsemide ER is precisely the pharmaceutical option that my colleagues and their patients have been asking for."

Loop diuretics are powerful drugs that force the body to expel sodium and water when damaged kidneys can no longer balance fluid levels. Among other therapeutic uses, these drugs are essential for patients with congestive heart failure suffering from water retention that stresses their already-taxed cardiovascular system. Doctors write tens of millions prescriptions for loop diuretics each year.

Sarfez has leveraged its highly sophisticated medical team and its ability to economize the drug development process to improve upon existing drugs in the marketplace. Its new formulation—Torsemide ER— releases the drug over 10 to 12 hours, stimulating the patient's kidneys during the day and allowing the drug to escape the body in time for a restful night's sleep, without awakening the patient for bladder relief.

Doctors have long worried about patients' compliance with their loop diuretics because existing formulas—often inconveniently—encourage the body to pass more than a liter of fluid within four hours or less. In addition, most doctors only prescribe loop diuretics for use once daily to preserve patients' electrolyte balance, leaving kidneys free to retain salt and water for 20 hours of the day.

"Clearly, what is needed is an effective diuretic, such as Torsemide ER, that releases slowly over a prolonged time to provide a steady and sustained drug effect on the kidney," said Peter U. Feig, M.D., Sarfez's chief medical officer. "This limits the time available for retention of salt and water after the diuretic action."

By addressing flaws in the current formulations, "Torsemide ER is a truly novel therapy," said Salim Shah, J.D., Ph.D., Sarfez's founder who brings two decades of international experience in biotechnology to the development of this drug. "Companies have tried and failed to come up with long-acting, powerful drugs that preserve the body's potassium—until now. Our expectations were exceeded during this trial of healthy volunteers, and we expect to see similar results as we continue to study this exciting drug."

About Sarfez Pharmaceuticals: Sarfez Pharmaceuticals brings together leading experts in nephrology, cardiology, pharmaceutical science and clinical research to redesign existing drugs with the goal of improving the quality of life of patients suffering from chronic ailments. The Sarfez team looks at the social and economic benefit of drug therapies and finds ways to get them to patients more economically than the traditional drug pipeline.

SOURCE Sarfez Pharmaceuticals

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