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

ABSTRACT

Introduction

Sarecycline is a novel, tetracycline-class antibiotic specifically designed to treat inflammatory acne. It offers a narrow spectrum of activity (mainly against Cutinebacterium acnes), and it shows less in vitro activity than other tetracyclines against enteric Gram-negative bacteria, offering advantages over older tetracyclines by decreasing the disruption of the gastrointestinal microbiome and the likelihood of developing bacterial resistance.

Areas covered

The drug’s pharmacology, safety profile, and clinical efficacy are discussed. Results of phase I, II and III clinical trials have shown that 1.5 mg/kg/day sarecycline is safe, well tolerated and more effective than placebo in treating inflammatory acne in patients 9 years old and older. Furthermore, sarecycline’s narrow spectrum of activity leads to a lower incidence of undesirable off-target antibacterial effects and consequently less adverse events such as diarrhea, fungal overgrowth and vaginal candidiasis.

Expert opinion

Sarecycline could become the first-line antibiotic therapy used in acne in the near future as it is an effective option for treating inflammatory acne lesions. Due to its narrow spectrum of activity, it could have a more adequate safety profile than older tetracyclines; however, head-to-head trials comparing the efficacy and safety profile of sarecycline with other tetracyclines are still needed to prove sarecycline’s superiority.

KEYWORDS:

• Acne vulgaris
• acne treatment
• tetracycline
• sarecycline
• oral acne treatment
• minocycline
• doxycline

Article highlights

• Sarecycline hydrochloride is an oral, once-daily, third generation tetracycline-class antibiotic approved in the USA in October 2018 specifically for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years old and older.

• Sarecycline’s narrow-spectrum of activity includes potent in vitro activity against C. acnes, with reduced activity against enteric Gram-negative bacteria when compared to minocycline, doxycycline and tetracycline, conferring sarecycline advantages over older tetracyclines by decreasing the likelihood of developing off-target bacterial effects such as disruption of the gastrointestinal microbiome and bacterial resistance.

• Phase I, II and III clinical trials results are discussed in detail and showed that 1.5mg/kg/day sarecycline is safe, well tolerated and more effective than placebo in treating inflammatory acne in patients 9 years old and older.

• Head-to-head studies comparing sarecycline to other commonly used tetracyclines for acne are still needed to determine sarecycine’s superiority in efficacy and safety.

This box summarizes key points contained in the article.

Declaration of interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants, or patents received or pending, or royalties.

Reviewer disclosures

One referee has received research, speaking and/or consulting support from Amgen, Galderma, GlaxoSmithKline/Stiefel, Almirall, Alvotech, Leo Pharma, Bristol-Myers Squibb, Boehringer Ingelheim, Mylan, Celgene, Pfizer, Ortho Dermatology, AbbVie, Samsung, Janssen Pharmaceuticals, Eli Lilly and Company, Menlo, Merck & Co, Novartis, Regeneron, Sanofi, Novan, Qurient, the National Biological Corporation, Caremark, Advance Medical, Sun Pharma, Suncare Research, Informa, UpToDate and the National Psoriasis Foundation. They are also affiliated with www.DrScore.com as well as Causa Research. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.