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Trimel Pharmaceuticals Corp Announces Positive Compleotrt Phase III Results For Secondary Efficacy And Safety Endpoints


Monday, 18 Mar 2013 07:00am EDT 

Trimel Pharmaceuticals Corp announced positive secondary efficacy endpoint and safety results from the CompleoTRT pivotal Phase III clinical study. These results complement the previously announced Phase III pivotal clinical trial results indicating that CompleoTRT met its primary efficacy endpoints. The pivotal study protocol included evaluations of the impact of treatment with CompleoTRT on body composition (total body mass, lean body mass, fat mass, percent body fat), bone mineral density, mood and erectile function. Following 90 days of CompleoTRT treatment, a statistically significant improvement over baseline was observed in all domains related to erectile function and mood. As well, CompleoTRT treatment demonstrated favourable trends with respect to its effect on bone mineral density and improvements in body composition parameters. The safety study results demonstrated that after 360 days of treatment, the CompleoTRT safety profile was consistent with currently marketed topical testosterone replacement therapies. There were no drug related serious adverse events observed at any safety time point during the study, and there was a decrease in mild and moderate drug related adverse events over time. Measures of nasal tolerability demonstrated that CompleoTRT was well tolerated in the nasal mucosa, with no adverse event trends. Trimel is moving forward as planned and expects to file the New Drug Application with the FDA in the second quarter of 2013. 

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0.63
-0.055 -8.03%
17 Apr 2014