dm+d

Unassigned

New Medicines

Seysara (US)Moderate-to-severe acne vulgaris

Information

Seysara (US)
New molecular entity
Paratek
Almirall

Development and Regulatory status

None
None
Launched
Nov 19Paratek is still currently exploring partnership opportunities to develop and approve sarecycline in appropriate markets outside the US [8].
Jan 19Launched in US [7].
Oct 18Approved in US for treatment in patients 9 years of age and older [5]
Dec 17The FDA has accepted a New Drug Application for sarecycline for treatment of moderate-to-severe acne vulgaris in patients 9 years of age and older [4].
Mar 17Paratek has retained rest of world (outside of the US) rights to sarecycline and is currently exploring partnership opportunities to develop and approve sarecycline in appropriate markets [3].
Mar 17Allergan intends to file in the US by end of 2017 [2].

Category

Once-daily narrow-spectrum tetracycline
Almost every teenager can expect to experience acne to some degree during the adolescent years although it is usually mild. Moderate-to-severe acne affects about 20% of young people [1].
Moderate-to-severe acne vulgaris
Oral

Trial or other data

Sep 18Almirall acquires Allergan´s US dermatology portfolio, including US rights to sarecycline [6].
Mar 17Allergan and Paratek announce that two Phase 3 trials of sarecycline for treatment of moderate to severe acne met their 12 week primary efficacy endpoints. Both SC1401 & SC1402 were designed to be replicative phase 3 randomized, multicenter, double-blind, placebo-controlled studies to evaluate the efficacy and safety of 1.5 mg/kg per day of sarecycline compared to placebo in the treatment of moderate to severe acne. The primary objective was to evaluate the efficacy and safety of oral sarecycline 1.5 mg/kg per day compared to placebo in treating inflammatory acne lesions in subjects with moderate to severe acne based on Investigators Global Assessment (IGA) scale score and inflammatory lesion counts. Patients were randomized (1:1) into two treatment groups to receive either sarecycline tablets (60 mg, 100 mg and 150 mg, providing a dose of 1.5 mg/kg/day) or placebo once a day for 12 weeks. Sarecycline was statistically significantly (p 2%) reported in the sarecycline group were nausea (3.2%), nasopharyngitis (2.8%), and headache (2.8%). The rate of discontinuation due to adverse events among sarecycline-treated patients in the two studies combined was 1.4% [2].