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Indevus Reports Additional Positive Phase III Trial Data for NEBIDO(R)
Date:1/22/2008

er by an additional 750 mg loading injection and then 750 mg every 10 weeks thereafter. Patients eligible for pharmacokinetic assessment were males with a diagnosis of either primary or secondary hypogonadism, a body weight >65 kg, and at least 18 years of age.

The primary endpoints included a responder analysis (based on guidelines provided from the FDA for average testosterone concentrations over the steady state dosing interval) and an outlier analysis (based on the maximum testosterone concentrations during the steady state dosing interval). Specifically, a responder was defined (per FDA approvability criteria) as a patient who, during steady state, had an average concentration of serum total testosterone (Cavg) within the normal range (300 to 1000 ng/dL). The primary response endpoint was met if at least 75% of patients achieved a Cavg within this normal range. FDA also provided guidelines related to maximum testosterone (Cmax) levels, including thresholds that no patient should exceed a testosterone concentration of 2500 ng/dL, no more than 5% of patients should exceed a concentration of 1800 ng/dL, and no more than 15% of patients should exceed a concentration of 1500 ng/dL.

In addition, secondary outcomes included measurements evaluating the general health and well-being of the patients by physical examinations, clinical laboratory measurements, questionnaires, and other assessments.

Study Findings

The trial enrolled a total of 130 male hypogonadal patients, with 117 (90%) patients completing their data collection for the assessment of the primary endpoints. Of these 117 patients, 94% had a Cavg within the normal range. None of these patients exceeded a testosterone level of either 2500 ng/dL or 1800 ng/dL, and only nine of 117 (7.7%) patients had a peak level exceeding 1500 ng/dL. For those few patients exceeding the 1500 ng/dL threshold, the duration of time above the threshold was brief. Patients also demonstrated improvements
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SOURCE Indevus Pharmaceuticals, Inc.
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