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Drug Evaluation

An overview of sarecycline for the treatment of moderate-to-severe acne vulgaris

Pages 145-154 | Received 28 Jun 2020, Accepted 18 Aug 2020, Published online: 14 Sep 2020

References

  • Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945–973.
  • Thiboutot DM, Dréno B, Abanmi A, et al. Practical management of acne for clinicians: an international consensus from the global alliance to improve outcomes in acne. J Am Acad Dermatol. 2018;78(2 suppl):S1–S23.
  • Gollnick HP, Bettoli V, Lambert J, et al. A consensus-based practical and daily guide for the treatment of acne patients. J Eur Acad Dermatol Venereol. 2016;30(9):1480–1490.
  • Nast A, Dreno B, Bettoli V, et al. European evidence-based (S3) guidelines for the treatment of acne. J Eur Acad Dermatol Venereol. 2012;26(Suppl 1):1–29.
  • Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J Dermatol. 2013;168(3):474–485.
  • Purdy S, De Berker D. Acne vulgaris. BMJ Clin Evid. 2011;2011:1714.
  • Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999;41(4):577–580.
  • Scholz CF, Kilian M. The natural history of cutaneous propionibacteria, and reclassification of selected species within the genus propionibacterium to the proposed novel genera acidipropionibacterium gen. nov., cutibacterium gen. nov. and pseudopropionibacterium gen. nov. Int J Syst Evol Microbiol. 2016;66(11):4422–4432.
  • Webster GF. The pathophysiology of acne. Cutis. 2005;76(2 suppl):4–7.
  • Burkhart CN, Gottwald L. Assessment of etiologic agents in acne 
pathogenesis. Skinmed. 2003;2:222–228.
  • Degitz K, Placzek M, Borelli C, et al. Pathophysiology of acne. J Dtsch Dermatol Ges. 2007;5(4):316–323.
  • Thiboutot D. Regulation of human sebaceous glands. J Invest Dermatol. 2004;123(1):1–12.
  • Holland DB, Jeremy AH, Roberts SG, et al. Inflammation in acne scarring: a comparison of the responses in lesions from patients prone and not prone to scar. Br J Dermatol. 2004;150(1):72–81.
  • Cong TX, Hao D, Wen X, et al. From pathogenesis of acne vulgaris to anti-acne agents. Arch Dermatol Res. 2019;311:337–349.
  • Jeremy AH, Holland DB, Roberts SG, et al. Inflammatory events are involved in acne lesion initiation. J Invest Dermatol. 2003;121(1):20–27.
  • Brown SK, Shalita AR. Acne vulgaris. Lancet. 1998;351(9119):1871–1876.
  • Eichenfield LF, Krakowski AC, Piggott C, et al. Evidence-based recommendations for the diagnosis and treatment of pediatric acne. Pediatrics. 2013;131(Suppl 3):S163–186.
  • Bienenfeld A, Nagler AR, Orlow SJ. Oral antibacterial therapy for acne vulgaris: an evidence based review. Am J Clin Dermatol. 2017;18(4):469–490.
  • Patel M, Bowe WP, Heughebaert C, et al. The development of antimicrobial resistance due to the antibiotic treatment of acne vulgaris: a review. J Drugs Dermatol. 2010;9(6):655–664.
  • Sapadin AN, Fleischmajer R. Tetracyclines: non-antibiotic properties and their clinical implications. J Am Acad Dermatol. 2006;54(2):258–265.
  • Farrah G, Tan E. The use of oral antibiotics in treating acne vulgaris: a new approach. Dermatol Ther. 2016;29(5):377–384.
  • Dreno B, Bettoli V, Ochsendorf F, et al. European recommendations on the use of oral antibiotics for acne. Eur J Dermatol. 2004;14(6):391–399.
  • Del Rosso JQ. A status report on the use of subantimicrobial-dose doxycycline: a review of the
biologic and antimicrobial effects of the tetracyclines. Cutis. 2004;74(2):118–122.
  • Del Rosso JQ. Oral doxycycline in the management of acne vulgaris: current perspectives on clinical
use and recent findings with a new double-scored
small tablet formulation. J Clin Aesthet Dermatol. 2015;8(5):19–26.
  • Roberts MC. Tetracycline therapy: update. Clin Infect Dis. 2003;36(4):462–467.
  • Smith K, Leyden JJ. Safety of doxycycline and minocycline: A systematic review. Clin Ther. 2005;27(9):1329–1342.
  • Mouser PE, Baker BS, Seaton ED, et al. Propionibacterium acnes-reactive T helper-1 cells in the skin of patients with acne vulgaris. J Invest Dermatol. 2003;121(5):1226–1228.
  • Chopra I, Roberts M. Tetracycline antibiotics: mode of action, applications, molecular biology, and epidemiology of bacterial resistance. Microbiol Mol Biol Rev. 2001;65(2):232–260.
  • Simonart T, Dramaix M, De Maertelaer V. Efficacy of tetracyclines in the treatment of acne vulgaris: a review. Br J Dermatol. 2008;158:208–216.
  • Griffin MO, Ceballos G, Villarreal FJ. Tetracycline compounds with non-antimicrobial organ protective properties: possible mechanisms of action. Pharmacol Res. 2011;63:102–107.
  • Weinberg JM. The anti-inflammatory effects of tetracyclines. Cutis. 2005;75(4 suppl):6–11.
  • Webster G, Del Rosso JQ. Anti-inflammatory activity of tetracyclines. Dermatol Clin. 2007;25(2):133–135.
  • Celerier P, Litoux P, Dréno B. Invitro modulation of epidermal inflammatory cytokines (IL-1 alpha, IL-6, TNF alpha) by minocycline. Arch Dermatol Res. 1996;288(7):411–414.
  • Becker E, Schmidt TSB, Bengs S, et al. Effects of oral antibiotics and isotretinoin on the murine gut microbiota. Int J Antimicrob Agents. 2017;50(3):342–351.
  • Ferrer M, Mendez-Garcia C, Rojo D, et al. Antibiotic use and microbiome function. Biochem Pharmacol. 2017;134:114–126.
  • Zaura E, Brandt BW, Teixeira de Mattos MJ, et al. Same exposure but two radically different responses to antibiotics: resilience of the salivary microbiome versus longterm microbial shifts in feces. mBio. 2015;6(6):e01693–01615.
  • Hinton NA. The effect of oral tetracycline HCl and doxycycline on the intestinal flora. Curr Ther Res Clin Exp. 1970;12(6):341–352.
  • Kircik LH. Doxycycline and minocycline for the management of acne: a review of efficacy and safety with emphasis on clinical implications. J Drugs Dermatol. 2010;9(11):1407–1411.
  • Garner SE, Eady A, Bennett C, et al. Minocycline for acne vulgaris: efficacy and safety. Cochrane Database Syst Rev. 2012;;2012(8):CD002086.
  • Nakase K, Nakaminami H, Takenaka Y, et al. Propionibacterium acnes is developing gradual increase in resistance to oral tetracyclines. J Med Microbiol. 2017;66(1):8–12.
  • Ozuguz P, Callioglu EE, Tulaci KG, et al. Evaluation of nasal and oropharyngeal flora in patients with acne vulgaris according to treatment options. Int J Dermatol. 2014;53(11):1404–1408.
  • Del Rosso JQ, Webster GF, Rosen T, et al. Status report from the scientific panel on antibiotic use in dermatology of the american acne and rosacea society: part 1: antibiotic prescribing patterns, sources of antibiotic exposure, antibiotic consumption and emergence of antibiotic resistance, impact of alterations in antibiotic prescribing, and clinical sequelae of antibiotic use. J Clin Aesthet Dermatol. 2016;9(4):18.
  • Bartlett JG, Bustetter LA, Gorbach SL, et al. Comparative effect of tetracycline and doxycycline on the occurrence of resistant Escherichia coli in the fecal flora. Antimicrob Agents Chemother. 1975;7(1):55–57.
  • Garrett JP, Margolis DJ. Impact of long-term antibiotic use for acne on bacterial ecology and health outcomes: a review of observational studies. Curr Dermatol Rep. 2012;1:23–28.
  • Barbieri JS, Hoffstad O, Margolis DJ. Duration of oral tetracycline-class antibiotic therapy and use of topical retinoids for the treatment of acne among general practitioners (GP): A retrospective cohort study. J Am Acad Dermatol. 2016;75:1142.
  • Barbieri JS, James WD, Margolis DJ. Trends in prescribing behavior of systemic agents used in the treatment of acne among dermatologists and nondermatologists: a retrospective analysis, 2004-2013. J Am Acad Dermatol. 2017;77(3):456–463.
  • Barbieri JS, Bhate K, Hartnett KP, et al. Trends in oral antibiotic prescription in dermatology, 2008 to 2016. JAMA Dermatol. 2019;155(3):290–297.
  • Wishart DS, Feunang YD, Guo AC, et al. DrugBank 5.0: sarecycline DB12035, a major update to the DrugBank database for 2018. Nucleic Acids Res. 2017;Nov8 10.1093/nar/gkx1037.
  • Center for Drug Evaluation and Research. Application number 209521Orig1s000. Multi-disciplinary review and Evaluation: Seysara (sarecycline) tablets. 2016. [Cited 2020 May 10]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209521Orig1s000MultidisciplineR.pdf
  • Hussar DA, Chahine EB. Omadacycline tosylate, sarecycline hydrochloride, rifamycin sodium and moxidectin. J Am Pharma Ass. 2019;59:756–760.
  • Hussar DA, Drugs N. 2020 Part 1. Nursing. 2020;50(2):31–38.
  • Kaul G, Saxena D, Dasgupta A, et al. Sarecycline hydrochloride for the treatment of acne vulgaris. Drus Today (Barc). 2019;55(10):615–625.
  • Deeks ED. Sarecycline: first global approval. Drugs. 2019;79:325–329.
  • Kircik LH. What’s new in the management of acne vulgaris. Cutis. 2019;104:48–52.
  • Karpiuk I, Tyski S. Looking for new preparations for antibacterial therapy IV New antimicrobial agents from the aminoglycoside, macrolide and tetracycline groups in clinical trials. Przegl Epidemiol. 2015;69:723–729.
  • U.S. department of health and human services: U.S. Food and drug administration. Drugs@FDA: FDA-approved drugs. New drug application (NDA) 209521 (Sarecycline). 2018. [Cited 2020 May 10]. Available from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=209521
  • U.S. Food and Drug Administration. New approval report: novel drugs approvals for 2018. 2019. [Cited 2020 May 10]. Available from: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2018
  • U.S. Food and Drug Administration. Almirall, Inc. Seysara: full prescribing information and FDA-approved patient labeling. 2018. [Cited 2020 May 10th]. Available from: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2018
  • Zhanel G, Critchley I, Lin LY, et al. Microbiological profile of sarecycline, a novel targeted spectrum tetracycline for the treatment of acne vulgaris. Antimicrob Agents Chemother. 2018;63:e01297–18.
  • Moore AY, Charles JEM, Moore S. Sarecycline: a narrow spectrum tetracycline for the treatment of moderate-to-severe acne vulgaris. Future Microbiol. 2019;14(14):1235–1242.
  • Garrido-Mesa N, Zarzuelo A, Gálvez J. Minocycline: far beyond an antibiotic. Br J Pharmacol. 2013;169:337–352.
  • Leyden JJ, Sniukiene V, Berk DR. Kaoukhov A: efficacy and safety of sarecycline, a novel, once-daily, narrow spectrum antibiotic for the treatment of moderate to severe facial acne vulgaris: results of a phase 2, dose-ranging study. J Drugs Dermatol. 2018;17(3):333–338.
  • Moore A, Green LJ, Bruce S, et al. Once-daily oral sarecycline 1.5 mg/kg/day is effective for moderate to severe acne vulgaris: results from two identically designed, phase 3, randomized, double-blind clinical trials. J Drugs Dermatol. 2018;17(9):987–996.
  • National Library of Medicine. National Center for Biotechnology Information. Compound summary: sarecycline. [Cited 2020 May 4th]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Sarecycline
  • Haidari W, Bruinsma R, Cardenas-de la Garza JA, et al. Sarecycline review. Ann Pharmacother. 2020;54(2):164–170.
  • Canadian Institute of Health Research. Drug bank: P- glycoprotein substrates. [Cited 2020 May 4th]. Available from: https://www.drugbank.ca/categories/DBCAT002668
  • Das S, Reynolds RV. Recent advances in acne pathogenesis: implications for therapy. Am J Clin Dermatol. 2014;15(6):479–488.
  • Pariser DM, Green LJ, Lain EL, et al. Results from a phase III, multicentre, open-label study and phase I phototoxicity study. J Clin Aesthet Dermatol. 2019;12(11):E53–E62.
  • Almirall SA A randomized, multicenter, double-blind, placebo-controlled study to evaluate the safety and efficacy of 3 different doses of a novel tetracycline compared to placebo in the treatment of facial acne vulgaris, study PR-10411. U.S. National Library of Medicine ClinicalTrials.gov. Last Update 1 Feb 2019. [Cited 2020 May 5]. Available from: https://clinicaltrials.gov/ct2/show/NCT01628549?term=P005672&draw=2&rank=1
  • Amirall SA A randomized, multicenter, double-blind, placebocontrolled study to evaluate the efficacy and safety of 1.5 mg/kg per day of sarecycline compared to placebo in the treatment of acne vulgaris. U.S. National Library of Medicine ClinicalTrials.gov. Last Update 15 Feb 2019. [Cited 2020 May 5]. Available from: https://clinicaltrials.gov/ct2/show/NCT02320149?term=SARECYCLINE&draw=2&rank=2
  • Amirall SA A randomized, multicenter, double-blind, placebocontrolled study to evaluate the efficacy and safety of 1.5 mg/kg per day of sarecycline compared to placebo in the treatment of acne vulgaris U.S. National Library of Medicine ClinicalTrials.gov. Last Update 1 Feb 2019. [Cited 2020 May 5th]. Available from: https://clinicaltrials.gov/ct2/show/NCT02322866?term=SARECYCLINE&draw=2&rank=3
  • Almirall SA A multi-center open-label evaluation of the safety of sarecycline tablets in the treatment of acne vulgaris. U.S. National Library of Medicine ClinicalTrials.gov. Last Update 1 Feb 2019. [Cited 2020 May 5]. Available from: https://clinicaltrials.gov/ct2/show/NCT02413346?term=SARECYCLINE&draw=2&rank=1
  • Dreno B, Thiboutot D, Gollnick H, et al. Antibiotic stewardship in dermatology: limiting antibiotic use in acne. Eur J Dermatol. 2014;24:330–334.
  • Thiboutot D, Dreno B, Gollnick H, et al. A call to limit antibiotic use in acne. J Drugs Dermato. 2013;12:1331–1332.
  • Gollnick HP, Buer J, Beissert S, et al. Verantwortlicher Umgang mit Antibiotika: notwendigkeit der Antibiotikareduktion in der Aknetherapie. J Dtsch Dermatol Ges. 2016;14:1319–1327.
  • Cho I, Blaser MJ. The human microbiome: at the interface of health and disease. Nat Rev Genet. 2012;13(4):260–270.
  • Lloyd-Price J, Abu-Ali G, Huttenhower C. The healthy human microbiome. Genome Med. 2016;8(1):51.
  • Santer M, Francis NA, Platt D, et al. Stemming the tide of antimicrobial resistance: implications for management of acne vulgaris. Br J Gen Pract. 2018;68(667):64–65.
  • Ross JI, Snelling AM, Carnegie E, et al. Antibiotic-resistant acne: lessons from Europe. Br J Dermatol. 2003;148:467–478.
  • Pulcini C, Gyssens IC. How to educate prescribers in antimicrobial stewardship practices. Virulence. 2013;4:192–202.
  • Disease NIoAaI. National institute of allergy and infectious diseases. Antimicrobial (drug) resistance. US department of health and human services, national institutes of health. Last update 11 Feb 2020. [Cited 2020 May 11]. Available from: https://www.niaid.nih.gov/research/antimicrobial-resistance
  • Klein NC, Cunha BA. Tetracyclines. Med Clin North Am. 1995;79(4):789–801.
  • Payne S, Gibson G, Wynne A, et al. In vitro studies on colonization resistance of the human gut microbiota to Candida albicans and the effects of tetracycline and Lactobacillus plantarum LPK. Curr Issues Intest Microbiol. 2003;4(1):1–8.
  • McCool L, Mai H, Essmann M, et al. Tetracycline effects on Candida albicans virulence factors. Infect Dis Obstet Gynecol. 2008;2008:493508.
  • Francino MP. Antibiotics and the human gut microbiome: dysbioses and accumulation of resistances. Front Microbiol. 2016;6:1543.
  • Jernberg C, Lofmark S, Edlund C, et al. Long-term impacts of antibiotic exposure on the human intestinal microbiota. Microbiology. 2010;156(Pt 11):3216–3223.
  • Langdon A, Crook N, Dantas G. The effects of antibiotics on the microbiome throughout development and alternative approaches for therapeutic modulation. Genome Med. 2016;8(1):39.
  • Ochsendorf F. Minocycline in acne vulgaris: benefits and risks. Am J Clin Dermatol. 2010;11(5):327–341.
  • Barza M, Brown RB, Shanks C, et al. Relation between lipophilicity and pharmacological behavior of minocycline, doxycycline, tetracycline, and oxytetracycline in dogs. Antimicrob Agents Chemother. 1975;8(6):713–720.
  • LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Sarecycline. [Updated 2019 Apr 10; cited 2020 May 16].  Avaialable fromhttps://www.ncbi.nlm.nih.gov/books/NBK548293/
  • LiverTox. Clinical and research information on drug- induced liver injury [Internet]. Tetracyclines bethesda (MD): national institute of diabetes and digestive and kidney diseases. 2012. Last Updated 10th April 2019. Cited 2020 May 16]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548040/
  • GoodRx. Sarecycline prices, coupons and savings tips. Last update March 2020. [Cited 2020 May 16]. Available from: https://www.goodrx.com/seysara
  • GoodRx. Doxycycline monohydrate prices, coupons and savings tips. Las t Update march 2020. [Cited 2020 May 16]. Available from: https://www.goodrx.com/doxycyclinemonohydrate
  • GoodRx. Minocycline prices, coupons and savings tips. [Cited 2020 May 16]. Available from: https://www.goodrx.com/minocycline

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