Seysara (sarecycline)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved October 2018

Specific Treatments:

moderate to severe acne vulgaris in patients 9 years of age and older

Therapeutic Areas

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General Information

Seysara (sarecycline) is an oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties.

Seysara is specifically indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. 

Seysara is supplied as a tablet for oral administration. If there is no improvement after 12 weeks, treatment should be reassessed. Seysara should be taken once daily, with or without food. To reduce the risk of esophageal irritation and ulceration, Seysara should be administered with adequate amounts of fluid. The recommended dose is based on body weight, as follows:

Body Weight: Tablet Strength:

33 to 54 kg      60 mg tablet

55 to 84 kg      100 mg tablet

85 to 136 kg    150 mg tablet

Clinical Results

FDA Approvals

The FDA approval of Seysara was based on two identically-designed, large, multicenter, randomized, double-blind, placebo-controlled, Phase III studies which assessed in a total of 2,002 subjects 9 years of age and older with moderate to severe facial acne vulgaris. Data demonstrated that once-daily sarecycline 1.5 mg/kg significantly improved acne severity based on Investigator's Global Assessment (IGA) success and significantly reduced inflammatory lesion count versus placebo at week 12. Study 1: IGA Success: 21.9% versus 10.5% and Mean absolute reduction in inflammatory lesions: 15.3 versus 10.2. Study 2: IGA Success 22.6% versus 15.3% and Mean absolute reduction in inflammatory lesions: 15.5 versus 11.1. 

Side Effects

The most common adverse reaction associated with the use of Seysara is nausea.

Mechanism of Action

Seysara (sarecycline) is an oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties. The mechanism of action of in treating acne vulgaris is not known. 

Additional Information

For additional information regarding Seysara or moderate to severe acne vulgaris in patients 9 years of age and older, please visit https://paratekpharma.com/