RESULTS OF ACNE DRUG STUDY REACHED

Critical Therapeutics announced that their Phase II study of ZYFLO Filmtab (zileuton tablets) in patients with moderate to severe inflammatory facial acne did not show statistical significance in its primary efficacy endpoint. The patients receiving zileuton did show positive responses to treatment and a trend toward significance in certain endpoints, but the responses did not achieve statistical significance as compared to the responses seen by patients receiving placebo.

The Phase II randomized, double-blind, placebo-controlled study involved 101 patients with moderate to severe inflammatory facial acne who received a 600 mg dosage of zileuton, four times daily, for 12 weeks. The study's primary efficacy endpoint was the number of inflammatory lesions. The number of noninflammatory lesions were also recorded.

The study found zileuton to be safe and well-tolerated, with no serious adverse events reported in patients. Moreover, there were no zileuton-treated patients discontinued from the study due to elevations of liver enzymes.