The US Food and Drug Administration (FDA) today approved sarecycline (Seysara, Almirall) for treating the inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
Seysara™ is specifically designed antibiotic for dermatologic use in four decades. The drug has narrow -spectrum of activity explicitly targeting acne and rosacea specific pathogens (P. acnes, Staphylococcus aureus) and has limited activity against aerobic gram-negative gastrointestinal organisms compared to minocycline and doxycycline.
Its anti-inflammatory property is a plus to treat the inflammation associated with skin lesions of acne, and long half-life enables convenient once a day dosing.
The approval follows the encouraging results of two replicative, Phase III, randomized, multicenter, double-blind, placebo-controlled studies that compared sarecycline to placebo. Sarecycline was administered in the dose of 1.5 mg/kg/day for 12 weeks. The studies looked at nearly 2000 patients aged 9 years and above and found the drug to be significantly effective in bringing down the inflammation as early as 3 weeks of starting treatment.
"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 am looking forward to having this as an option for my patients when it becomes available in 2019," Leon Kircik, MD, who participated in clinical trials for Seysara.
Allergan has U.S. rights to the development and commercialization of Seysara and has assigned such rights to Almirall SA, while Paratek retains all ex-U.S. rights.
Common side effects noted were nausea, headache, and nasopharyngitis, but the discontinuation rates because of side effects were as low as 1.4%.
The drug is contraindicated in patients with hypersensitivity to any of the tetracyclines and may cause permanent tooth discoloration if used during the tooth development phase. It should only be used when indicated to avoid development of antimicrobial resistance and should be discontinued in the event of Clostridium difficile-associated diarrhea (antibiotic-associated colitis), or intracranial hypertension occur.
According to GlobalData analysis acne vulgaris (acne) is one of the most common dermatological conditions, affecting around 90% of the world’s population at some point in their lifetime. Other major classes of drugs used for the treatment of acne are retinoids, anti-androgens, antibiotics, and benzoyl peroxide.
Sarecycline will face competitions from two late-stage pipeline drugs with antibiotic properties: Foamix Pharmaceuticals’ FMX-101 and Dermira’s olumacostat glasaretil. Along with these drugs, Sarecycline will provide newer treatment options for patients with acne vulgaris.
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