QLT announces positive findings from Phase IV G6PD deficiency study for Aczone(TM) in acne
QLT Inc. announced positive results of a Phase IV clinical trial of Aczone(TM) in more than 50 patients with G6PD deficiency that was performed to meet a post-approval commitment requested by the FDA. 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.
During a 6-month period, patients were treated with both Aczone and the Aczone-vehicle (control group) in a cross-over design. An initial analysis of the data was undertaken by third party clinical experts in dermatology and hematology and they have concluded that no clinically meaningful changes in safety-related parameters were observed in the trial. QLT USA 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.
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