FDA approves Seysara ( sarecycline )

Paratek Pharmaceuticals announced on October 2 that the FDA approved Seysara (sarecycline) for the treatment of moderate to severe acne in people over 9 years of age.

Sarecycline is a once-a-day, oral, narrow-spectrum tetracycline-derived antibiotic with anti-inflammatory properties that can be used as a potential treatment for moderate to severe acne in a community setting.

Paratek is a biopharmaceutical company specializing in the chemical synthesis and commercial development of tetracycline. Another core product, omadacycline, is a new generation of aminomethylcyclotetracycline with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. 

Sarecycline is a semi-synthetic derivative of tetracycline that was initially discovered by Paratek Pharmaceuticals from Boston, MA but then licensed to Warner Chilcott of Rockaway, NJ in July of 2007 [A40005]. After completing various phase-II and phase-III trials demonstrating its effectiveness in treating moderate to severe facial acne vulgaris [A39993, A39994] the US Food and Drug Administration approved Barcelona based Almirall, S.A.'s Seysara (sarecylcine) as a new first in class narrow spectrum tetracycline derived oral antibiotic for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients nine years of age and older [L4814]. Seysara (sarecycline) was originally part of Allergan's US Medical Dermatology portfolio, before Almirall acquired the portfolio in the second half of 2018 as a means of consolidating and reinforcing the dermatology-focused pharmaceutical company's presence in the United States [L4815]. Acne vulgaris itself is a common chronic skin condition associated with the blockage and/or inflammation of hair follicles and their accompanying sebaceous glands [L4814]. The acne often presents physically as a mixture of non-inflammatory and inflammatory lesions mainly on the face but on the back and chest as well [L4814]. Based upon data from Global Burden of Disease studies, the acne vulgaris condition affects up to 85% of young adults aged 12 to 25 years globally - with the possibility of permanent physical and mental scarring resulting from cases of severe acne [L4814]. Subsequently, while a number of first line tetracycline therapies like doxycycline and minocycline do exist for treating acne vulgaris, sarecycline presents a new and innovative therapy choice because it exhibits the necessary antibacterial activity against relevant pathogens that cause acne vulgaris but also possesses a low propensity for resistance development in such pathogens and a narrower, more specific spectrum of antibacterial activity, resulting in fewer off-target antibacterial effects on endogenous intestinal flora and consequently fewer resultant adverse effects associated with diarrhea, fungal overgrowth, etc.

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

SEYSARA is a drug used to treat certain types of moderate to severe acne vulgaris in patients 9 years and older.

Acne vulgaris is a skin disease characterized by oily skin, blackheads or whiteheads, pimples, and sometimes scarring.

How is this drug used?

SEYSARA is a tablet taken by mouth once daily. The dose is based on body weight.

What are the benefits of this drug?

More patients achieved a reduction in the number of inflammatory acne (pimples) and clear or almost clear skin after 12 weeks of treatment with SEYSARA in comparison to those who were treated with placebo.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

• Sex: SEYSARA worked similarly in males and females.
• Race: SEYSARA worked similarly in White and Black or African American patients. The number of patients in other races was limited; therefore, differences in how SEYSARA worked among other races could not be determined.
• Age: SEYSARA worked similarly among patients younger than and older than 18 years of age.