Overall, the population entered this study with significant comorbidities. Approximately 20% had type 2 diabetes, 37% were diagnosed with hypertension and 70% had a BMI over 30. Approximately 79% had a significant risk factor for cardiovascular disease. Taking these facts into consideration, Androxal was generally well tolerated.
Also, with approximately 50% of subjects up-titrated to the higher dose, it is remarkable that there was no dose response noted in the incidence of adverse events. If anything, adverse events of note could have easily been attributed to raising of testosterone or just general age effects. For example 7.4% of subjects exhibited an elevation in PSA of 0.75 ng/ml or more. This is consistent with the experience reported for Androgel ®. As men were followed for two months after treatment, those men that experienced an increase in PSA generally returned to baseline levels as their T receded.
In the instance of DVT in Repros studies, Androgel ® has exhibited a higher frequency of increased hematocrit and hemoglobin than Androxal. Increased erythropoiesis directly affects an increased risk of developing a thromboembolic adverse event.
Several tables giving more in depth analysis of the safety profile determined from the study are available at the Company's website, www.reprosrx.com .Repros has exposed over 1,350 subjects to at least a single dose of Androxal. Almost 800 subjects have been exposed for at least 6 months of treatment. This represents over 90% of the safety database anticipated for the NDA filing. Joseph Podolski, President and CEO noted, "We are encouraged by these outcomes. Our NDA filing remains on track for mid-2014. We believe we have the organization to successfully complete the required work and we have begun to prepare the necessary manufacturing documentation for the regulatory submission as well as having launch drug product available for an anticipated approval during 2015. The Company is in a strong financial position to maximize this unique Androxal opportunity."
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