Sarecycline is the new drug approved for Acne by FDA

Sarecycline is the new drug approved by the US Food and Drug Administration (FDA) for inflammatory lesions associated with non-nodular moderate to severe acne vulgaris. It is a new first-in-class tetracycline-derived oral antibiotic for patients aged 9 years and older with specifically designed for dermatologic use in more than four decades.

SEYSARA (sarecycline) is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting. It can be safely taken with or without food without compromising efficacy.

The 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. 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. The efficacy of Seysara beyond 12 weeks and its safety beyond 12 months have not been determined. It significantly reduced inflammatory lesions as early as 3 weeks after beginning treatment.

"We are proud to have obtained the FDA's approval for Seysara, which will bring a new option for the many patients with unmet medical needs," Peter Guenter, chief executive officer, Almirall, said in the news release.

The clinical trials have not established efficacy beyond 12 weeks nor safety beyond 12 months, and sarecycline was not evaluation for the treatment of infections.

"As dermatologists, we are always seeking ways to improve the management of our patients' disease. The results of the studies are encouraging, with statistically significant efficacy vs placebo as early as 3 weeks. I'm looking forward to having this as an option for my patients when it becomes available in 2019," Leon Kircik, MD, a leading dermatologist from Louisville, Kentucky, and a sarecycline clinical trialist, said in the news release.

Seysara is generally safe and well-tolerated, according to Almirall. Its use has been associated with central nervous system side effects, including light-headedness, dizziness, and vertigo. The most frequently seen adverse effect (incidence ≥ 1%) is nausea.

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

It is contraindicated in those with hypersensitivity to any of the tetracyclines and may cause permanent tooth discoloration if used during tooth development.

Sarecycline should be used only as indicated to avoid the development of antimicrobial-resistant bacteria as well as to promote the effectiveness of other antibacterial medications and should be discontinued if Clostridium difficile-associated diarrhea (antibiotic-associated colitis) or intracranial hypertension occurs.

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.The study found 80% of Americans have been affected at some point during their lives, with 20% of those developing severe acne, which can cause permanent physical and emotional scarring.