Efficacy

Amzeeq provides the
trusted legacy of minocycline

Amzeeq delivers minocycline directly on the skin, and systemic absorption is very low5,10
~750X* LOWER SYSTEMIC EXPOSURE WITH Amzeeq COMPARED TO ORAL MINOCYCLINE
Interventional maximum use pharmacokinetic study
  • Adult patients, 18 years or older with acne vulgaris, were administered 1 single dose of oral minocycline extended-release tablets dosed 1 mg/kg
  • Following a 10-day wash-out period, patients then began topical Amzeeq 4% therapy dosed 4 g/day (8X the recommended dose in clinical trials) applied for 21 days
absorption graphic
Clinical significance of lower systemic exposure with Amzeeq is unknown.
  • The overall pediatric population showed 2.4-fold and 2.7-fold higher Cmax and AUCO-24h compared to the adult population
  • There were no significant differences in the minocycline pharmacokinetics within the pediatric population among subjects 10 years to less than 17 years of age with acne vulgaris
  • *730-765.
  • Blood samples were obtained before and after administration of oral minocycline and each topical application of Amzeeq 4% on days 1, 12, and 21.
Amzeeq was evaluated in a large population of patients over three studies10
Large phase 3 trials were conducted, leading to Amzeeq's approval for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older.
trial design 2418 patients graphic
trial design 9 years graphic
trial design 12 weeks graphic
40 week open study icon
KEY INCLUSION/EXCLUSION CRITERIA
  • 20-50 inflammatory lesions (papules, pustules, nodules) and 25-100 noninflammatory lesions (open, closed comedones)
  • IGA 6-point scale–moderate or severe (grade 3 or 4)
  • No other topical or systemic acne medication was permitted for use during these studies
CO-PRIMARY EFFICACY ENDPOINTS
  • Absolute change from baseline in inflammatory lesion count at Week 12
  • IGA endpoint success at Week 12, where success is defined as an IGA score of 0 or 1 (clear or almost clear), and at least a 2-grade improvement (decrease) from baseline
safety evaluations
  • Adverse events, physical exams, vitals, dermal tolerability, labs
  • Study 1 (2:1) N=466; Study 2 (2:1) N=464; Study 3 (1:1) N=1488.
  • §Patients in Studies 1 and 2 who completed the first 12 weeks, and with an IGA score that had not worsened when compared to baseline at Week 12 (N=657).
  • IGA=Investigator's Global Assessment
Amzeeq demonstrated improvement in inflammatory lesions and IGA scores at Week 1210
Statistically significant absolute change in inflammatory lesion count at Week 12
absolute inflammatory lesion reduction chart
absolute inflammatory lesion reduction results
  • An additional 40-week, open-label, extension safety study (up to 52 weeks of treatment) demonstrated continued increase in efficacy throughout treatment period12
IGA score of "clear" or "almost clear" at week 12
IGA percentage at clear or almost clear chart
IGA percentage at clear or almost clear results
Amzeeq consistently reduced inflammatory acne over the 12-week study period10
Statistically significant Reduction in inflammatory lesions at 12 weeks
percent reduction inflammatory lesions study 1 chart
percent reduction inflammatory lesions study 1 results
percent reduction inflammatory lesions study 2 chart
percent reduction inflammatory lesions study 2 results
percent reduction inflammatory lesions study 3 chart
percent reduction inflammatory lesions study 3 results
Real patients, visible results
IMAGES FROM CLINICAL STUDIES13

The average percent reduction in inflammatory lesions and percent of patients achieving IGA endpoint success at Week 12 was -43% to -54% and 8.1% to 30.8%, respectively.##

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