Sarecycline Granted FDA Approval for Acne Vulgaris

Officials with the FDA have approved sarecycline (Seysara, Paratek and Almirall) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged 9 years and older.^1-2 The drug is expected to be available in the United States market in January.¹

Efficacy of Seysara was assessed in a pair of 12-week, multicenter, randomized, double-blind, placebo-controlled studies with 2,002 participants aged 9 years and older.¹ The 2 co-primary efficacy endpoints were the percentage of subjects with Investigator's Global Assessment success and absolute reduction from baseline in inflammatory lesion counts at Week 12.^1-2 The efficacy of Seysara beyond 12 weeks and its safety beyond 12 months have not been determined.²

Leon Kircik, a Louisville, KY dermatologist and saracycline clinical trialist, said results of the studies were encouraging. In a prepared statement, Kircik noted that statistically significant efficacy vs placebo was shown as early as 3 weeks.¹

"As dermatologists we are always seeking ways to improve the management of our patients' disease," said Kircik, in the statement.¹ "I'm looking forward to having this as an option for my patients when it becomes available in 2019."

According to the FDA, no clinically significant differences in the pharmacokinetics of sarecycline were observed by age, weight, sex, renal impairment, or mild to moderate heptatic impairment. The effects of end-stage renal disease, and severe hepatic impairment on saracycline pharmacokinetics was not assessed.²

Seysara is generally safe and well-tolerated, according to Almirall. The most common adverse reaction to the drug is nausea (> 1%).¹

Seysara is an oral antibiotic taken with or without food, but should be administered with fluid in order to reduce the risk of esophageal irritation and ulceration. The recommended dosage is once daily, as follows:²

• 60 mg for patients who weigh 33-54 kg
• 100 mg for patients who weigh 55-84 kg
• 150 mg for patients who weigh 85-136 kg

Globally, acne vulgaris affects 85% of individuals aged 12 to 25 years. The condition affects 80% of people in the United States at some point in their lives, and 20% have severe acne that can result in permanent physical and mental scars.¹

References

• FDA approves Seysara™, a New Chemical Entity for moderate to severe acne [news release]. Barcelona, Spain; October 2, 2018: Almirall website. https://www.almirall.com/en/media/press-releases/media-detail-new?title=fda-approves-seysaratm-a-new-chemical-entity-for-moderate-to-severe-acne&articleId=3540239. Accessed October 3, 2018.
• FDA Approves SEYSARA (Sarecycline) for Inflammatory Lesions of Non-Nodular Moderate to Severe Acne Vulgaris in Patients 9 Years of Age and Older [news release]. Silver Spring, MD; October 3, 2018: FDA Office of Clinical Pharmacology, Office of Translational Sciences, CDER.