The Food and Drug Administration (FDA) has approved updated labeling for Seysara® (sarecycline; Almirall LLC) to include information stating that Propionibacterium acnes (recently renamed Cutibacterium acnes) strains displayed a low propensity for the development of resistance to sarecycline.

Seysara is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients ≥9 years old.

The Microbiology section has been updated with this information to promote the appropriate use of antibiotics due to concerns regarding antimicrobial resistance to which the Centers for Disease Control and Prevention (CDC) has stressed antibiotic stewardship. According to a study assessing the microbiological profile of sarecycline, spontaneous mutation frequencies were found to be similar to those for minocycline and vancomycin (10−10 at 4 to 8 times the minimum inhibitory concentration [MIC]).

The efficacy of sarecycline beyond 12 weeks and safety beyond 12 months have not been established. The drug has also not been evaluated in the treatment of infections and should only be used as indicated.


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“When considering the importance of antibiotic stewardship, this new data for sarecycline provides another reason to consider it as a viable treatment option for inflammatory lesions of non-nodular moderate to severe acne,” commented Dr Lawrence Eichenfield, Professor of Dermatology and Pediatrics at the University of California, San Diego and Rady Children’s Hospital, San Diego.

The product is supplied as 60mg, 100mg, and 150mg strength tablets in 30-count bottles.

For more information visit seysara.com.

This article originally appeared on MPR