Tp Anda Holdings

DAPSONE

dapsone gel, 5%

Post-LOE

TOPICAL · GEL

12.1 Mechanism of Action The mechanism of action of dapsone gel in treating acne vulgaris is not known. 12.3 Pharmacokinetics An open-label study compared the pharmacokinetics of dapsone after Dapsone Gel, 5%, (110 ± 60 mg/day) was applied twice daily (~BSA 22.5%) for 14 days (n=18) with a single 100 mg dose of oral dapsone administered to a subgroup of patients (n=10) in a crossover design. On Day 14 the mean dapsone AUC 0 - 24h was 415 ± 224 ng•h/mL for Dapsone Gel, 5%, whereas following a single 100 mg dose of oral dapsone the AUC 0-infinity was 52,641 ± 36,223 ng•h/mL. Exposure after the oral dose of 100 mg dapsone was approximately 100 times greater than after the topical Dapsone Gel, 5% dose, twice a day. In a long-term safety study of Dapsone Gel, 5% treatment, periodic blood samples were collected up to 12 months to determine systemic exposure of dapsone and its metabolites in approximately 500 patients. Based on the measurable dapsone concentrations from 408 patients (M=192, F=216), obtained at month 3, neither gender, nor race appeared to affect the pharmacokinetics of dapsone. Similarly, dapsone exposures were approximately the same between the age groups of 12-15 years (N=155) and those greater than or equal to 16 years (N=253). There was no evidence of increasing systemic exposure to dapsone over the study year in these patients. 12.4 Microbiology In Vivo Activity: No microbiology or immunology studies were conducted during dapsone gel clinical trials. Drug Resistance: No dapsone resistance studies were conducted during dapsone gel clinical trials. Because no microbiology studies were done, there are no data available as to whether dapsone treatment may have resulted in decreased susceptibility of Propionibacterium acnes, an organism associated with acne, to other antimicrobials that may be used to treat acne. Therapeutic resistance to dapsone has been reported for Mycobacterium leprae, when patients have been treated with oral dapsone.

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