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Drugs

, Volume 79, Issue 3, pp 325–329 | Cite as

Sarecycline: First Global Approval

  • Emma D. DeeksEmail author
AdisInsight Report

Abstract

Sarecycline (Seysara™) is an oral, once-daily, tetracycline-class drug for which a tablet formulation is approved in the USA for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged ≥ 9 years. The drug was developed by Paratek and Allergen and later acquired by Almirall S.A. (a Barcelona-based pharmaceutical company focused on medical dermatology). Sarceycline tablets were approved in early October 2018 and are planned to be available for patients in January 2019. Sarecycline capsules have also been studied in the USA, but no recent reports of development have been identified for this formulation. There are currently no clinical trials underway assessing sarecycline in rosacea. This article summarizes the milestones in the development of sarecycline leading to this first approval for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris.

Notes

Compliance with Ethical Standards

Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Emma Deeks is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

References

  1. 1.
    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 e33.CrossRefGoogle Scholar
  2. 2.
    Hauk L. Acne vulgaris: treatment guidelines from the AAD. Am Fam Physician. 2017;95(11):740–1.Google Scholar
  3. 3.
    Mayo Clinic. Acne. 2017. https://www.mayoclinic.org/. Accessed 18 Oct 2018.
  4. 4.
    Del Rosso JQ, Gallo RL, Thiboutot D, et al. Status report from the Scientific Panel on Antibiotic Use in Dermatology of the American Acne and Rosacea Society. Part 2: perspectives on antibiotic use and the microbiome and review of microbiologic effects of selected specific therapeutic agents commonly used by dermatologists. J Clin Aesthet Dermatol. 2016;9(5):11–7.Google Scholar
  5. 5.
    Sinnott SJ, Bhate K, Margolis DJ, et al. Antibiotics and acne: an emerging iceberg of antibiotic resistance? Br J Dermatol. 2016;175(6):1127–8.CrossRefGoogle Scholar
  6. 6.
    U.S. Food and Drug Administration. Novel drug approvals for 2018. 2018. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm592464.htm. Accessed 18 Oct 2018.
  7. 7.
    Allergan Pharmaceuticals International Limited. Seysara (Sarecycline) tablets for oral use: US prescribing information. 2018. https://www.accessdata.fda.gov/. Accessed 18 Oct 2018.
  8. 8.
    Warner Chilcott. Warner Chilcott and Paratek Pharmaceuticals sign collaboration agreement for novel, narrow-spectrum agents for acne and rosacea [media release]. 9 July 2007. http://www.warnerchilcot.com.
  9. 9.
    Almirall Canada. Almirall buys Allergan’s US dermatology portfolio for $650 million [media release]. 3 Aug 2018. http://www.almirall.com.
  10. 10.
    Almirall S.A. Almirall acquires Allergan U.S. medical dermatology portfolio [media release]. 21 Sep 2018. http://www.almirall.com.
  11. 11.
    U.S. Securities and Exchange Commission. Form 10-K: Paratek Pharmaceuticals, Inc. 2016. https://www.sec.gov/Archives/edgar/data/1178711/000156459017003144/prtk-10k_20161231.htm. Accessed 18 Oct 2018.
  12. 12.
    Data on file, Allergan plc, 2018.Google Scholar
  13. 13.
    Center for Drug Evaluation and Research. Application number 209521Orig1s000. Multi-discipline review. 2018. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209521Orig1s000MultidisciplineR.pdf. Accessed 10 Jan 2019.
  14. 14.
    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):987–96.Google Scholar
  15. 15.
    US National Institutes of Health. ClinicalTrials.gov identifier NCT02413346. 2018. https://clinicaltrials.gov. Accessed 17 Oct 2018.
  16. 16.
    Leyden JJ, Sniukiene V, Berk DR, et al. 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):333–8.Google Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

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