FDA Approves Sarecycline for Moderate to Severe Acne

Troy Brown, RN

Disclosures

October 02, 2018

The US Food and Drug Administration (FDA) has approved sarecycline (Seysara, Almirall) for patients aged 9 years and older with inflammatory lesions associated with non-nodular moderate to severe acne vulgaris. Sarecycline is a new first-in-class tetracycline-derived oral antibiotic and the first one specifically designed for dermatologic use in 40 years, according to a company news release.

"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.

Sarecycline is a once-daily oral tablet with anti-inflammatory properties that can be taken with or without food.

The approval follows consideration of data from two 12-week multicenter, randomized, double-blind, placebo-controlled studies that assessed efficacy in a total of 2002 patients aged 9 years and older that found the drug to be safe and effective. It significantly reduced inflammatory lesions as early as 3 weeks after beginning treatment.

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.

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

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 occur.

The Global Burden of Disease study found 85% of young adults aged 12 to 25 years are affected by the disorder globally, according to the news release. 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.

Almirall recently acquired sarecycline for the United States as part of Allergan's Medical Dermatology portfolio and is expected to be available in January 2019.

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