The purpose of this study was to gather more information about the safety of Aczone, a prescription topical medicine, in treating patients with acne who have certain blood disorders.
In the FDA requested study, patients were treated with both Aczone and the Aczone-vehicle in a cross-over design. According to QLT, an initial analysis of the data concluded that no clinically meaningful changes in safety-related parameters were observed in the trial.
QLT said it intends to submit a label revision supplement to the FDA during the first quarter of 2007. A decision by the FDA on the label review is expected to take approximately 10 months.
“Based on the strength of this data we plan to engage the FDA in discussions with a goal of removing the requirement for blood testing for all patients treated with Aczone. QLT will decide how best to commercialize the product based on interactions with the FDA,” said Bob Butchofsky, president and CEO of QLT.