AUXILIUM ANNOUNCES RESULTS OF ANDROGEN REPLACEMENT TRIAL

Auxilium Pharmaceuticals has announced top-line findings from the Phase II trial for its androgen replacement product candidate. Auxilium's product candidate utilizes proprietary transmucosal film technology to deliver testosterone.

This Phase II Proof of Concept trial evaluated plasma testosterone levels, tolerability and patient acceptance of testosterone delivery with the film. The study design involved treating 69 hypogonadal men with various doses of the testosterone transmucosal film. The daily dose levels employed in the study were 5, 10 and 15 mg of testosterone delivered via film.

The results demonstrate that the testosterone transmucosal film can produce increased serum testosterone levels. This data has allowed Auxilium to narrow the three tested doses to the lowest dose employed in the study. The data also showed that the film was well-tolerated. With regard to patient acceptability, 97 percent of those involved in the trial rated the transmucosal film either desirable (49 percent) or acceptable (48 percent).

Auxilium's transmucosal film technology is a delivery mechanism in the form of a thin strip. The film is applied by the patient to the gum above the back molar, and, because it is biodegradable, completely dissolves. Auxilium's testosterone replacement film product candidate is intended to restore and maintain serum testosterone levels in men with abnormally low testosterone levels and associated symptoms, a condition also known as hypogonadism.