A recent mid-stage clinical trial conducted by Critical Therapeutics Inc. has revealed that the asthma drug Zyflo, also known as zileuton, is ineffective in treating severe acne. The study found that Zyflo did not significantly outperform placebos in reducing inflammatory lesions.
During the 12-week trial, patients receiving Zyflo experienced an average reduction of 11.5 inflammatory lesions, compared to a reduction of 9.1 lesions in the placebo group. This difference was not statistically significant. While Zyflo-treated patients showed a mean reduction of 25.3 in the total number of lesions versus 16.4 in the placebo group, the drug ultimately failed to meet the trial’s primary endpoint.
A company spokeswoman, Linda Lennox, indicated that Critical Therapeutics may conduct a larger trial to further investigate Zyflo’s potential as an acne treatment, utilizing insights gained from this initial trial. The company, headquartered in Lexington, Massachusetts, is currently analyzing the data and collaborating with researchers to better understand the results. Zyflo functions by blocking the 5-lipoxygenase (5-LO) enzyme, which causes inflammation. It received FDA approval in 1996 for asthma treatment in patients aged 12 and older. Originally owned by Abbott Laboratories Inc., the drug was later licensed to Critical Therapeutics in 2003.