Indevus reports additional positive Phase III trial data of Nebido

The dosing regimen for Nebido (testosterone undecanoate) submitted in the original NDA was 1000mg given every 12 weeks. This recently completed additional Phase III trial has studied a new treatment regimen in which hypogonadal men were given an initial injection of 750mg of Nebido, followed four weeks later by an additional 750mg loading injection and then 750mg injections every ten weeks thereafter.

In the trial, Nebido demonstrated a rapid achievement of steady state testosterone levels, minimal excursions outside of the normal range, and an extremely high percentage of patients maintaining a eugonadal (normal) testosterone range. Nebido met its primary endpoints, 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 trial data has been filed with the FDA as an addition to data contained in the company’s existing new drug application (NDA) that was originally filed on August 28, 2007. The company now anticipates that the FDA Prescription Drug User Fee Act (PDUFA) target action date for Nebido will remain June 27, 2008.

Glenn Cooper, chairman and CEO of Indevus, said: “Steady state testosterone pharmacokinetics were achieved within just weeks under the new regimen, whereas the 1000 mg regimen, while successfully achieving all primary objectives, reached steady state pharmacokinetics after several months of treatment.”