Auxilium start testosterone-replacement trial

By Elaine Rigoli

Tampa, Fla., June 29 - Auxilium Pharmaceuticals, Inc. has begun enrolling patients with hypogonadism in a pivotal phase 3 trial of AA2600, the company's testosterone-replacement transmucosal film-product candidate.

The trial is expected to enroll 240 patients at about 25 centers in the United States, according to a news release.

Patients will be randomized at a 2:1 ratio to receive either AA2600 or a buccal testosterone tablet.

"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," executive vice president of research and development Jyrki Mattila said in the release.

Hypogonadism is a condition that is estimated to affect about 20% of the U.S. male population over age 50 and 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.

Auxilium is a specialty pharmaceutical company located in Malvern, Pa.

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