Aczone Gel is Approved for the Treatment of Acne by the FDA
VANCOUVER, British Columbia, July 07, 2005 - QLT Inc. announced today that it has received final approval from the U.S. Food and Drug Administration (FDA) to market Aczone (dapsone) Gel, 5% for the topical treatment of acne vulgaris.
Patients will need to be screened to detect if they are predisposed to one type of anemia (hemolytic anemia) because of a specific enzyme deficiency, G6PD (Glucose 6-phosphate dehydrogenase) deficiency. Patients who have this enzyme deficiency will need to be monitored with regular blood counts. In the Aczone clinical trial program, 1.4% of about 3500 patients had this disorder which is consistent with the incidence in the general North American population. Certain populations, mainly males of African American descent, have a higher reported incidence of approximately 10-14%. QLT will undertake a post-approval Phase IV study in 50 acne patients who have G6PD deficiency and follow them for 6 months, after which QLT expects to submit an application to the FDA to re-evaluate the Aczone label.
"We are very pleased with the FDA's decision and confident in Aczone's potential as a new class of treatment for acne patients," said Paul Hastings, President and Chief Executive Officer of QLT Inc. "Aczone represents an important clinical advance in dermatology, has demonstrated safety and efficacy in over 4,000 patients, and is an important first step for QLT to market our own products and establish our own commercial organization."
Aczone gel 5% 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 owns worldwide marketing rights to Aczone, which was developed by QLT USA, Inc., a wholly owned subsidiary of QLT.
Aczone is an aqueous topical gel containing 5% dapsone. Combining dapsone in a Solvent Microparticulate (SMP) gel enables dapsone to be applied topically and safely. In two randomized double-blind, vehicle controlled clinical studies in 3000 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.
Source: QLT Inc.
Posted: July 2005