ACZONE^® (dapsone) Gel 5% to calm inflammatory acne

• First in class for acne. First new FDA-approved chemical entity for topical acne treatment in a decade

Dapsone—now in a well-tolerated topical treatment

• Application site adverse events comparable to vehicle¹
• Most were mild to moderate¹

Large pivotal studies

• 3010 study subjects²

Findings:

• ACZONE^® Gel works fast² and works well—notable results within 2 weeks
  • 24% reduction in inflammatory lesions as early as week 2²
  • 35% at week 4²
• Especially on inflammatory acne²
  • 48% reduction in inflammatory lesions at week 12²
  Results for vehicle: 2 weeks 22%, 4 weeks 31%, 6 weeks 35%, 8 weeks 38%,12 weeks 42%.

No blood test required for ACZONE^® Gel¹

• No evidence of clinically relevant hemolysis or anemia in patients treated with ACZONE^® Gel, including those who were G6PD deficient¹

SMP™ Delivery System

• Advanced Solvent Micro Particulate (SMP™) delivery system
• Used exclusively in ACZONE^® Gel Vehicle
• Dissolved dapsone permeates stratum corneum³
• In vitro data suggest undissolved dapsone remains in the pilosebaceous unit ⁴
• The properties of the diethylene glycol monomethyl ether (DGME) component helps facilitate permeation into the skin⁵

Role of neutrophils in acne inflammation⁶

The mechanism of action of dapsone gel in treating acne vulgaris is not known. Inflammatory events may be involved in even the earliest stages of acne lesions.⁶

1. In vitro studies suggest dapsone may suppress neutrophil recruitment
   • Dapsone is thought to interfere with neutrophil chemotactic migration⁷
   • This inhibition suppresses neutrophil recruitment and local production of toxic respiratory and secretory products⁷
2. In vitro studies suggest dapsone may inhibit oxidation
   • Dapsone appears to protect cells from neutrophil (and eosinophil) mediated injury by directly inhibiting the generation of toxic, oxygen-derived radicals⁷
   • This inhibition suppresses neutrophil recruitment and local production of toxic respiratory and secretory products⁷

Dapsone may also have antimicrobial activity

Clinical significance of this data is unknown.

Learn more about ACZONE^® Gel efficacy >

ACZONE^® (dapsone) Gel 5% is indicated for the topical treatment of acne vulgaris.

Important Safety Information

WARNINGS AND PRECAUTIONS

Hematological effects: Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs. There was no evidence of clinically relevant hemolysis or anemia in patients treated with ACZONE^® Gel 5%, including patients who were G6PD deficient. Some subjects with G6PD deficiency using ACZONE^® Gel developed laboratory changes suggestive of mild hemolysis.

If signs and symptoms suggestive of hemolytic anemia occur, ACZONE^® Gel 5% should be discontinued. ACZONE^® Gel 5% should not be used in patients who are taking oral dapsone or antimalarial medications because of the potential for hemolytic reactions. Combination of ACZONE^® Gel 5% with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of hemolysis in patients with G6PD deficiency.

Peripheral neuropathy: Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No events of peripheral neuropathy were observed in clinical trials with topical ACZONE^® Gel 5% treatment.

Skin: Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria) have been reported with oral dapsone treatment. These types of skin reactions were not observed in clinical trials with topical ACZONE^® Gel 5% treatment.

ADVERSE REACTIONS:

The most common adverse reactions of ACZONE^® Gel 5% (incidence ≥ 10%) are oiliness/peeling, dryness, and erythema at the application site.

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