The makers of Aczone announced today that Health Canada has completed its review of Aczone labeling supplement for Aczone and has removed the glucose-6-phosphate dehydrogenase (G6PD) screening and blood monitoring requirements.
“We are extremely pleased to report Health Canada’s decision to remove the need for blood monitoring from the Aczone label,” said Bob Butchofsky, President and Chief Executive Officer of QLT. “This positive review, along with the FDA’s recent decision to also remove the need for blood monitoring from the Aczone label, validates our regulatory strategy, increases Aczone’s commercial potential, and enhances the product’s overall attractiveness to potential acquirers.”
Aczone was originally approved by Health Canada in June 2006 with a similar label restriction as that required by the US Food and Drug Administration (FDA). The label called for all patients to undergo G6PD screening and for those patients with this enzyme deficiency, regular blood monitoring was required during Aczone treatment. On March 17, 2008 the Company announced that the FDA removed the G6PD screening and monitoring requirements based on a Phase IV clinical trial in 56 safety-evaluable G6PD-deficient patients. During a six-month period, patients were treated with both Aczone and the Aczone-vehicle (control group) in a cross-over design. Data was analyzed by third party clinical experts in dermatology and hematology who concluded that no clinically meaningful changes in safety-related parameters were observed in the trial.
Aczone, a prescription topical medicine for the treatment of acne vulgaris, is the only acne treatment to harness the potential of dapsone in a topical formulation to provide patients with a convenient and effective therapy. QLT USA owns worldwide marketing rights to Aczone.
ACZONE is an aqueous topical gel containing 5% dapsone. Combining dapsone in a proprietary Solvent Microparticulate gel enables dapsone to be applied topically and safely. In two randomized double-blind, vehicle-controlled clinical studies in 3,000 acne patients, ACZONE Gel achieved statistically significant percent reduction in the number of acne lesions and better success rate on the Global Acne Assessment Score. The most common adverse events reported from controlled clinical trials include oiliness/peeling, dryness, and erythema. There were no significant differences in the adverse event rates between ACZONE Gel and vehicle control treated patients.