Mixed Results for Auxilium Drug in Diabetes Study
Posted on: Thursday, 15 June 2006, 18:00 CDT
By Linda Loyd, The Philadelphia Inquirer
Jun. 15--Auxilium Pharmaceuticals Inc., a specialty pharmaceutical company in Malvern, said today a study of its topical testosterone gel helped men with Type II diabetes lose fat and gain muscle in a clinical trial.
Both are important factors in managing Type II diabetes.
But the study did not show a statistically significant difference in hemoglobin blood-sugar levels in patients treated with the drug, Testim, which was the primary endpoint of the study. The company is considering seeking an expansion of the product's label to indicate that Testim might be used "an adjunct treatment for diabetes."
Auxilium said it will evaluate the data to decide whether to design a new patient trial to measure for hemoglobin and blood sugar.
The study of 204 patients showed that those treated with Testim experienced a statistically significant improvement in serum testosterone levels compared with those receiving a placebo. Patients treated with Testim also had a statistically significant increase in lean body mass, or muscle mass, and a decrease in fat mass compared with the control group, confirming results from previous studies.
Testim is a marketed testosterone gel that treats hypogonadism, or low testosterone levels, a condition that affects about 20 percent of U.S. males over 50. About 33 percent to 40 percent of men with Type II diabetes have low testosterone levels.
Testim sales accounted for most of Auxilium's 2005 revenue of $42.8 million.
Shares fell 20 cents, or 2.3 percent, to $8.44 in early afternoon trading.
Contact staff writer Linda Loyd at 215-854-2831 or lloyd@phillynews.com.
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Copyright (c) 2006, The Philadelphia Inquirer
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NASDAQ-NMS:AUXL,
Source: The Philadelphia Inquirer
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