Seysara (sarecycline), a novel tetracycline-derived oral antibiotic developed specifically for the treatment of acne, is now commercially available, announced the pharmaceutical company Almirall. Seysara was approved in October 2018 by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe non-nodular inflammatory acne vulgaris in patients 9 years of age and older.
Seysara, a once-daily, oral, narrow spectrum tetracycline-derived antibiotic, was the first new chemical entity for the treatment of acne to be approved by the FDA in a decade.
Approval of the drug was based on two large, multicenter, randomized, double-blind, placebo-controlled identical Phase 3 clinical trials (SC1401 and SC1402). The trials involved patients with moderate to severe acne vulgaris.
Findings of the Trial:
- A significant number of patients receiving once-daily Seysara experienced improvement of their acne severity at 12 weeks versus placebo based on the Investigator’s Global Assessment (IGA) (21.9% vs 10.1% SC1401; 22.6% vs 15.3% SC1402).
- Seysara also led to a reduction in the number of inflammatory acne lesions at 12 weeks (51.8% vs 35.1% SC1401; 49.9% vs 35.4% SC1402), with significant results seen as early as week 3 (29.6% vs 22.4% SC1401; 28% vs 18.6% S1402).
- Patients receiving Seysara reported no cases of vertigo or tinnitus and fewer cases of dizziness than seen in the placebo group.
- Less than one percent of patients experienced photosensitivity or sunburn, and rates of GI issues were relatively low. The most common adverse reaction (incidence ≥ 1%) was nausea.
“Unlike most other pivotal acne studies, the Seysara trials analyzed the impact of the study drug on chest and back acne where it was also shown to be effective,” stated Angela Moore, a coordinating investigator and Clinical Assistant Professor in Dermatology at the University of Texas Southwestern (UTSW), “In addition, this will be one of very few acne treatments that are FDA approved for patients 9 years of age.” The efficacy of Seysara beyond 12 weeks and safety beyond 12 months have not been established.
Seysara is available as 60mg, 100mg, and 150mg strength tablets; the recommended dosage is based on body weight. To reduce the risk of esophageal irritation and ulceration, Seysara should be taken with an adequate amount of fluids.
About Acne Vulgaris
Acne vulgaris is a common skin condition involving blockage and/or inflammation of hair follicles and their glands, which can present as non-inflammatory lesions, inflammatory lesions, or a mixture of both, affecting the face, back and chest. According to the Global Burden of Disease study, acne vulgaris affects 85 percent of young adults aged 12–25 years around the world.