45. Biswal I, Gaind R, Kumar N, Mohanty S, Manchanda V, Khunger N, V R, Deb M. In vitro antimicrobial susceptibility patterns of Propionibacterium acnes isolated from patients with acne vulgaris. J Infect Dev Ctries. 2016;10(10):1140-1145.
46. Eady EA, Jones CE, Gardner KJ, Taylor JP, Cove JH, Cunliffe WJ. Tetracyclineresistant propionibacteria from acne patients are cross-resistant to doxycycline, but sensitive to minocycline. Br J Dermatol. 1993;128(5):556-60.
47. Schwartz BS, Graber CJ, Diep BA, Basuino L, Perdreau-Remington F, Chambers HF. Doxycycline, not minocycline, induces its own resistance in multidrug-resistant, community-associated methicillin-resistant Staphylococcus aureus clone USA300. Clin Infect Dis. 2009;48(10):1483-4.
48. Leyden JJ. The evolving role of Propionibacterium acnes in acne. Semin Cutan Med Surg. 2001;20(3):139-143.
49. Yong VW, Wells J, Giuliani F, Casha S, Power C, Metz LM. The promise of minocycline in neurology. Lancet Neurol. 2004;12:744-51.
50. Stewart DM, Torok HM, Weiss JS, Plott RT; Solodyn Phase 2 Study Group. Dose-ranging efficacy of new once-daily extended-release minocycline for acne vulgaris. Cutis. 2006;78(4 Suppl):11-20.
51. Seukeran DC, Eady EA, Cunliffe WJ. Benefit-risk assessment of acne therapies. Lancet. 1997; 349(9060):1251-2.
52. Amzeeq™ [Package Insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212379 s000lbl.pdf. Accessed April 21, 2021.
53. Kircik L, Del Rosso JQ, Weiss JS, et al. Formulation and Profile of FMX101 4% Minocycline Topical Foam for the Treatment of Acne Vulgaris. J Clin Aesthet Dermatol. 2020;13(4):14-21.
54. Gold LS, Dhawan S, Weiss J, Draelos ZD, Ellman H, Stuart IA. A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Results of 2 randomized, double-blind, phase 3 studies. J Am Acad Dermatol. 2019;80(1):168-177.
55. Paik J. Topical Minocycline Foam 4%: A Review in Acne Vulgaris. Am J Clin Dermatol. 2020;21(3):449-456.
56. Sutcliffe J, McLaughlin R, Webster G, et al. Susceptibility of Cutibacterium acnes to topical minocycline foam. Anaerobe. 2020;62:102169.
57. Jones TM, Ellman H, deVries T. Pharmacokinetic Comparison of Once-Daily Topical Minocycline Foam 4% vs Oral Minocycline for Moderate-to-Severe Acne. J Drugs Dermatol. 2017;16(10):1022-1028.
58. Fleischer AB, Dinehart S, Stough D, et al. Safety and efficacy of a new extended-release formulation of minocycline. Cutis. 2006;78(4 Suppl):21-31.
59. Leyden JJ. Extended-release minocylcine – the first systemic antibiotic approved for the treatment of acne: introduction. Cutis. 2006;78(4S):4–5.
60. MinoLira™ Tablets [Package Insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfdadocs/label/2017/209269s 000lbl.pdf. Accessed April 21,2021.
61. Kallakunta VR, Sarabu S, Tiwari RV. Multiple Unit particle Systems (MUPS), a Versatile Strategy for Controlled Drug Delivery: Focus on Formulation and Process Concerns. J Formul Sci Bioavailab. 2017;1:1.
62. Jedinger N, Khinast J, Roblegg E. The design of controlled-release formulations resistant to alcohol-induced dose dumping–a review. Eur J Pharm Biopharm. 2014;87(2):217-226.
63. Celerion Clinical Study Report No. CA16742, Contained in MinoLira™ NDA 209269.
64. Guidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation. https://www.fda.gov/media/81626/download. Accessed April 22, 2021.
65. Baldwin HE, Nighland M, Kendall C, Mays DA, Grossman R, Newburger J. 40 years of topical tretinoin use in review. J Drugs Dermatol. 2013;12(6):638-42.
46. Eady EA, Jones CE, Gardner KJ, Taylor JP, Cove JH, Cunliffe WJ. Tetracyclineresistant propionibacteria from acne patients are cross-resistant to doxycycline, but sensitive to minocycline. Br J Dermatol. 1993;128(5):556-60.
47. Schwartz BS, Graber CJ, Diep BA, Basuino L, Perdreau-Remington F, Chambers HF. Doxycycline, not minocycline, induces its own resistance in multidrug-resistant, community-associated methicillin-resistant Staphylococcus aureus clone USA300. Clin Infect Dis. 2009;48(10):1483-4.
48. Leyden JJ. The evolving role of Propionibacterium acnes in acne. Semin Cutan Med Surg. 2001;20(3):139-143.
49. Yong VW, Wells J, Giuliani F, Casha S, Power C, Metz LM. The promise of minocycline in neurology. Lancet Neurol. 2004;12:744-51.
50. Stewart DM, Torok HM, Weiss JS, Plott RT; Solodyn Phase 2 Study Group. Dose-ranging efficacy of new once-daily extended-release minocycline for acne vulgaris. Cutis. 2006;78(4 Suppl):11-20.
51. Seukeran DC, Eady EA, Cunliffe WJ. Benefit-risk assessment of acne therapies. Lancet. 1997; 349(9060):1251-2.
52. Amzeeq™ [Package Insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212379 s000lbl.pdf. Accessed April 21, 2021.
53. Kircik L, Del Rosso JQ, Weiss JS, et al. Formulation and Profile of FMX101 4% Minocycline Topical Foam for the Treatment of Acne Vulgaris. J Clin Aesthet Dermatol. 2020;13(4):14-21.
54. Gold LS, Dhawan S, Weiss J, Draelos ZD, Ellman H, Stuart IA. A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Results of 2 randomized, double-blind, phase 3 studies. J Am Acad Dermatol. 2019;80(1):168-177.
55. Paik J. Topical Minocycline Foam 4%: A Review in Acne Vulgaris. Am J Clin Dermatol. 2020;21(3):449-456.
56. Sutcliffe J, McLaughlin R, Webster G, et al. Susceptibility of Cutibacterium acnes to topical minocycline foam. Anaerobe. 2020;62:102169.
57. Jones TM, Ellman H, deVries T. Pharmacokinetic Comparison of Once-Daily Topical Minocycline Foam 4% vs Oral Minocycline for Moderate-to-Severe Acne. J Drugs Dermatol. 2017;16(10):1022-1028.
58. Fleischer AB, Dinehart S, Stough D, et al. Safety and efficacy of a new extended-release formulation of minocycline. Cutis. 2006;78(4 Suppl):21-31.
59. Leyden JJ. Extended-release minocylcine – the first systemic antibiotic approved for the treatment of acne: introduction. Cutis. 2006;78(4S):4–5.
60. MinoLira™ Tablets [Package Insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfdadocs/label/2017/209269s 000lbl.pdf. Accessed April 21,2021.
61. Kallakunta VR, Sarabu S, Tiwari RV. Multiple Unit particle Systems (MUPS), a Versatile Strategy for Controlled Drug Delivery: Focus on Formulation and Process Concerns. J Formul Sci Bioavailab. 2017;1:1.
62. Jedinger N, Khinast J, Roblegg E. The design of controlled-release formulations resistant to alcohol-induced dose dumping–a review. Eur J Pharm Biopharm. 2014;87(2):217-226.
63. Celerion Clinical Study Report No. CA16742, Contained in MinoLira™ NDA 209269.
64. Guidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation. https://www.fda.gov/media/81626/download. Accessed April 22, 2021.
65. Baldwin HE, Nighland M, Kendall C, Mays DA, Grossman R, Newburger J. 40 years of topical tretinoin use in review. J Drugs Dermatol. 2013;12(6):638-42.
AUTHOR CORRESPONDENCE
Daniel B. Ward Jr. MD daniel.ward@dejconsulting.com
