FDA filing ahead of schedule for Tostrex

Cellegy Pharmaceuticals has completed enrollment of subjects into anongoing Phase III trial of its Tostrex, a transdermal testosterone gel for the treatment of hypogonadism in males.

Based on analyses of results from the first 163 patients enrolled in the study, and following a pre-New Drug Application meeting with the US Food and Drug Administration, the company plans to submit an NDA ahead of its previously-announced schedule. The firm says the results from a small number of subjects who have not yet completed the trial will still be incorporated into the NDA, which is now expected to be submitted during the first quarter of 2002.

"Results of the analyses, conducted by Cellegy and a panel of outside experts, show that Tostrex doses could be adjusted to predictably restore average daily testosterone blood levels to normal in greater than 90% of testosterone-deficient men who completed the study," noted the firm's senior vice president, clinical and regulatory affairs, Daniel Azarnoff. "The product also produced significant improvements in bone density of the spine and hip, an important consideration for men whose bone density has deteriorated and who may therefore have an increased risk of fractures," he added.