FDA Approves New Acne Treatment

10/03/2018
acne

The FDA recently approved sarecycline (Seysara), a first-in-class tetracycline derived oral antibiotic, for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged 9 years and older.  

Sarecycline is an oral antibiotic that is taken once per day with or without food. 
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Approval was based on results from 2 multicenter, randomized, double-blind, placebo-controlled trials that included a total of 2002 participants. Participants who received sarecycline experienced significant reductions in inflammatory lesions after 12 weeks of treatment, with some participants experiencing improvements in lesions as early as 3 weeks.

The most common adverse reaction was nausea. Other central nervous system adverse events associated with tetracycline use included light-headedness, dizziness, and vertigo. Sarecycline should be discontinued if patients develop Clostridium difficile associated diarrhea or intracranial hypertension. In addition, sarecycline use during tooth development can cause permanent discoloration of the teeth. The efficacy of sarecycline has not been assessed beyond 12 weeks, and safety has not been determined beyond 12 months.