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news.Indevus Pharmaceuticals said that its phase III pharmacokinetic trial for Nebido long- acting injectable testosterone therapy for the treatment of male hypogonadism met its primary endpoints.
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Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. Reduced testosterone levels can lead to health problems and significantly impair quality of life.
The company said that over the 48-week trial, Nebido demonstrated a responder analysis based on average testosterone concentrations during the steady state dosing interval and an outlier analysis based on the maximum testosterone concentrations during the steady state dosing interval. The drug was well tolerated.
A responder was defined (per the FDA) 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. In addition, secondary outcomes included measurements evaluating the general health and well-being of the patients by questionnaires and assessment tools.
“I am extremely pleased to report the successful completion of our Nebido study and we are looking forward to the submission of our NDA later this summer,” said Glenn Cooper, chairman and CEO of Indevus.
“The results of our trial demonstrate the potential of Nebido, the only once every three month treatment for male hypogonadism, to dramatically improve the treatment options for men who suffer from this condition.”
Indevus acquired US rights to Nebido from Bayer Schering in July 2005.