A Randomized, Multicenter, Double-blind, Placebocontrolled Study to Evaluate the Efficacy and Safety of 1.5 mg/kg Per Day of Sarecycline Compared to Placebo in the Treatment of Acne Vulgaris
Phase of Trial: Phase III
Latest Information Update: 20 Dec 2017
At a glance
- Drugs Sarecycline (Primary)
- Indications Acne vulgaris
- Focus Registrational; Therapeutic Use
- Sponsors Actavis; Warner Chilcott
- 20 Dec 2017 According to an Allergan media release, the U.S. Food and Drug Administration (FDA) has accepted to review a New Drug Application (NDA) of Seysara(sarecycline) for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older and expects the Prescription Drug User Fee Act (PDUFA) action date to occur in the second half of 2018.
- 27 Mar 2017 Results published in an Allergan media release.
- 27 Mar 2017 Primary endpoint (Investigator Global Assement (IGA) Success) has been met, according to an Allergan media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History