Hypogonadism is a condition that is estimated to affect approximately 20% of the US male population over age 50. It is characterized by reduced or deficient secretion of testosterone, which can lead to symptoms such as loss of libido, adverse changes in body composition, irritability and poor attention span.
“Delivering testosterone replacement therapy through an oral transmucosal film may provide men efficacy results equivalent to approved transdermal treatments but with quicker release of testosterone and lower dosing,” said Dr Jyrki Mattila, Auxilium’s executive vice president of R&D. “We believe that, if confirmed, these delivery advantages will be viewed favorably by physicians and patients.”
The pivotal trial is designed to evaluate the efficacy and safety of AA2600 in patients diagnosed with hypogonadism. The trial is expected to enroll 240 patients at approximately 25 centers across the US.
Patients will be randomized to receive either AA2600 (5mg or 7.5mg BID) or a buccal testosterone tablet (30mg BID), respectively. Patients’ outcomes will be evaluated after three months of treatment for both impact on serum testosterone levels and secondary efficacy parameters, as well as for tolerability.