Sarecycline Review

Abstract

Objective: Sarecycline is a new oral tetracycline antibiotic recently approved by the US Food and Drug Administration. The aim of this article was to evaluate the data from published clinical trials of sarecycline in the treatment of acne, review the drug’s pharmacology, and understand how this new medication may apply to clinical practice. Data Sources: A systematic literature review was performed using the terms sarecycline (Seysara), P005672, and WC-3035 in the MEDLINE and EMBASE databases. ClinicalTrials.gov was searched to identify ongoing or nonpublished studies. Study Selection and Data Extraction: Articles in English between January 2000 and April 2019 relating to clinical trials, pharmacology, safety, and microbiological profile were evaluated. Data Synthesis: In a phase 3 clinical trial (SC1401), absolute change from baseline in facial inflammatory lesion count at week 12 was −15.3 for the sarecycline arm and −10.1 for placebo ( P < 0.01). In another phase 3 clinical trial (SC1402), the absolute change in this category was −15.7 for sarecycline and −10.7 for placebo ( P < 0.01). Mean percentage change in facial inflammatory lesion count was higher in the sarecycline group than in the placebo group in both studies ( P < 0.01). Relevance to Patient Care and Clinical Practice: The 1.5-mg/kg sarecycline dose has efficacy in reducing inflammatory lesions, is well tolerated, and has more targeted antimicrobial activity, which may help reduce the risk of developing antibiotic resistance. Conclusions: This novel, once-daily treatment may represent a useful treatment for patients with moderate to severe acne.

<p>Sarecycline: A Review of Preclinical and Clinical Evidence</p>

“…[6][7][8][9][10] Side effect profiles have also limited the use of oral tetracyclines in some patients, including gastrointestinal (GI) complications, phototoxicity, dizziness, vertigo, benign intracranial hypertension (pseudotumor cerebri), lupus-like syndrome, changes in pigmentation, and urticaria. [11][12][13][14] Sarecycline is a novel tetracycline-derived drug, specifically designed for acne, with a narrow antibacterial spectrum when compared to previously available broad-spectrum tetracycline-class antibiotics; it was FDA-approved in October 2018 for once-daily treatment of inflammatory lesions of non-nodular moderate to severe AV in patients ≥9 years of age. 15 Here, we will review the pharmacology and clinical characteristics of sarecycline that are believed to relate to its therapeutic potential.…”

New Acne Therapies and Updates on Use of Spironolactone and Isotretinoin: A Narrative Review

“…Tetracycline specific adverse effects were also seen with sarecycline use including vulvovaginal candidiasis (study 1: 1.1% versus 0%; study 2: 0.3% versus 0%), vulvovaginal mycotic infections (study 1: 0.7% versus 0%; study 2: 1.0% versus 0%), and sunburn (study 1: 0.6% versus 0.4%; study 2: 0.2% versus 0.2%) compared with placebo [11]. No vestibular side effects were reported with the exception of vomiting [11], and no QT prolongation was identified even at supratherapeutic levels [9]. Similar to other tetracyclines, sarecycline is not recommended for use during pregnancy or breastfeeding [9].…”

“…Due to sarecycline's narrow spectrum of antibacterial activity, it has potential to be a tetracycline alternative with less risk of antibiotic resistance. However, sarecycline is significantly more expensive than others in its class and its accessibility to patients should be considered [9]. Direct comparisons with other tetracyclines are needed to establish its efficacy within the tetracycline class.…”

“…No vestibular side effects were reported with the exception of vomiting [11], and no QT prolongation was identified even at supratherapeutic levels [9]. Similar to other tetracyclines, sarecycline is not recommended for use during pregnancy or breastfeeding [9].…”

“…Oral sarecycline is a narrow-spectrum tetracycline-class antibiotic with antiinflammatory properties [9]. Sarecycline displays antibacterial activity against Cutibacterium acnes equal to that of other tetracyclines.…”