The US Food and Drug Administration’s approval of Almirall’s Seysara (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients ages nine and older is set to shake up the currently stagnant acne market due to its ease of administration and once-daily formulation, predicts GlobalData, a data and analytics company.
Seysara was originally developed by Paratek Pharmaceuticals. The company exclusively licensed US development and commercialization rights to Allergan and retains the development and commercialization rights to Seysara for the rest of the world. Almirall recently acquired Allergan’s Medical Dermatology portfolio, and now has the rights to Seysara in the US. Seysara is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties.
“Seysara will provide an alternative treatment to target P. acnes colonization and inflammation to those acne patients whose strains of P. acnes have already developed antibiotic resistance to clindamycin and erythromycin. As a once-daily oral tablet, Seysara should make treatment easier for patients,” says Pavan Kottamasu, MBA, MSc, Senior Pharma Analyst at GlobalData.
The efficacy and safety of Seysara were observed in two replicative, randomized, multicenter, double-blind, placebo-controlled Phase III studies that compared sarecycline to placebo. The primary outcome measures were absolute change in inflammatory lesion count and Investigator Global Assessment (IGA) success from baseline to Week 12. Seysara was found to be statistically, significantly superior (p < 0.004) to placebo, with respect to both primary efficacy endpoints.
The most common adverse events reported were nausea, nasopharyngitis, and headache. The rate of discontinuation due to adverse events among sarecycline-treated patients in the two studies combined was 1.4%.
“Although the clinical trial evidence suggest that Seysara is efficacious and safe to use, the use of any antibiotic can lead to antibiotic resistance via pump efflux or ribosomal protection. Tetracycline-derived antibiotics are also well known to cause adverse effects such as hyperpigmentation in teeth, gastrointestinal irritation, and photosensitivity,” says Kottamasu.
In addition, Seysara will potentially face competition from FMX101, Foamix Pharmaceuticals’ Phase III drug with antibiotic properties that is also in development for the treatment of moderate to severe acne vulgaris. In September 2013, Foamix announced positive topline results for their Phase III trial evaluating FMX101 in moderate to severe acne patients. The study met both co-primary endpoints of absolute change from baseline in inflammatory lesion count at Week 12, and IGA treatment success at Week 12.
“The acne vulgaris pharmaceutical landscape has been stagnant for the past five years. Innovative novel products can challenge the treatment paradigm, such that compliance, the greatest unmet need for acne vulgaris patients, is improved and allows patients to receive the full benefit of a drug’s efficacy,” says Kottamasu.