Sarecycline Tablets (Seysara)
February 15, 2019
By William Elliott, MD, FACP, and James Chan, PharmD, PhD
Dr. Elliott is Assistant Clinical Professor of Medicine, University of California, San Francisco.
Dr. Chan is Associate Clinical Professor, School of Pharmacy, University of California, San Francisco.
Drs. Elliott and Chan report no financial relationships relevant to this field of study.
The FDA has approved a narrow-spectrum tetracycline-class antibiotic for the treatment of moderate to severe acne vulgaris. Sarecycline is distributed as Seysara.
INDICATIONS
Sarecycline is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne in patients 9 years of age and older.1
DOSAGE
The recommended dosage is based on body weight.1 For patients who weigh 33-54 kg, the dosage is 60 mg once daily. For patients who weigh 55-84 kg, the dosage is 100 mg once daily. For patients who weigh 85-136 kg, the dosage is 150 mg once daily. Sarecycline is available as 60 mg, 100 mg, and 150 mg tablets.
POTENTIAL ADVANTAGES
Sarecycline is active against gram-positive cocci but is 16- to 32-fold less active than the commonly used minocycline and doxycycline against gram-negative bacilli.2 Sarecycline also is less active than other tetracyclines against gram-positive and gram-negative anaerobic organisms. Potentially, this means there is a lower effect on the normal intestinal microbiome, which may reduce the risk of the emergence of tetracycline-resistant organisms (including overgrowth of Candida albicans).2 The drug is dosed once a day, potentially improving compliance.
POTENTIAL DISADVANTAGES
The efficacy and safety beyond 12 weeks have not been established.1 The most frequently reported adverse reaction was nausea (4.6% vs. 2.6% for placebo).1 Sarecycline shares the same warnings as the tetracycline class (e.g., teratogenic effects, intracranial hypertension, photosensitivity).1
COMMENTS
The efficacy and safety of sarecycline was evaluated in two, 12-week, randomized, double-blind, placebo-controlled trials that included 2,002 subjects.1,3,4 Subjects had moderate to severe facial acne and scored ≥ 3 on the Investigator Global Assessment (IGA) scale. IGA is a five-point scale assessing acne severity as clear, almost clear, mild, moderate, and severe. In addition, subjects had 20-50 inflammatory lesions and ≤ 100 noninflammatory lesions, and ≤ 2 nodules. These subjects were randomized to sarecycline 1.5 mg/kg/day or placebo. There were two coprimary endpoints: percentage of subjects’ IGA success (defined as a score of clear [0] or almost clear [1]) and absolute reduction from baseline in inflammatory lesion counts.
IGA success rates vs. placebo were 21.9% vs. 10.5% in trial 1 and 22.6% vs. 15.3% in trial 2. Mean absolute reductions in inflammatory lesions were 15.3 vs. 10.2 in trial 1 and 15.5 vs. 11.1 in trial 2. Mean percent reductions were 52.2% vs. 35.2% in trial 1 and 50.8% vs. 36.4% in trial 2. Researchers observed a reduction in inflammatory lesions by the first visit (week 3) and in noninflammatory lesions between weeks 6 and 9. The authors of an open-label extension study did not observe any significant safety issues among participants receiving sarecycline for up to 40 weeks.3,6 Participants in this extension study were treated until adequate improvement in facial acne was achieved. Treatment restarted if acne recurred.
CLINICAL IMPLICATIONS
Acne is a common inflammatory disorder most often affecting adolescents but also adults.5 Systemic antibiotics are recommended for moderate and severe acne and forms of inflammatory acne that are resistant to topical treatment.5 Doxycycline and minocycline are used commonly. Sarecycline is the first narrow-spectrum tetracycline-class antibiotic developed for acne by targeting Cutibacterium acnes (formerly known as Propionibacterium acnes) as well as other important skin/soft tissue pathogens with little or no activity against enteric gram-negative bacilli. It is unknown whether this potential advantage will translate into measurable clinical benefit. The cost for sarecycline is $1,032 for a 30-day supply.
REFERENCES
- Allergan. Seysara Prescribing Information, October 2018. Available at: https://bit.ly/2AFzR2W. Accessed Jan. 22, 2019.
- Zhanel G, Critchley I, Lin LY, Alvandi N. Microbiological profile of sarecycline, a novel targeted spectrum tetracycline for the treatment of acne vulgaris. Antimicrob Agents Chemother 2018;63. pii: e01297-18. doi: 10.1128/AAC.01297-18. Print 2019 Jan.
- Center for Drug Evaluation and Research. Mutli-Disciplinary Review and Evaluation. Seysara (sarecycline) tablets. Available at: https://bit.ly/2RUg3CH. Accessed Jan. 22, 2019.
- 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;17:987-996.
- Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol 2016;74:945-973.
- ClinicalTrials.gov. A multi-center open-label evaluation of the safety of sarecycline tablets in the treatment of acne vulgaris. Available at: https://bit.ly/2sDqFrh. Accessed Jan. 22, 2019.
Sarecycline is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne in patients 9 years of age and older.
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