Sep. 10, 2020: “Sol-Gel Technologies, a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases announced that its NDA for Epsolay® (benzoyl peroxide), an investigational proprietary topical cream for the treatment of inflammatory lesions of rosacea, containing 5% encapsulated benzoyl peroxide, has been accepted for filing by the U.S.FDA.
The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for Epsolay is April 26, 2021.
The NDA filing is based on two positive, identical Phase 3 randomized, double-blind, multicenter, 12-week, clinical trials that evaluated the safety and efficacy of Epsolay compared to vehicle in patients with papulopustular rosacea (N = 733).
In both trials, Epsolay demonstrated a statistically significant improvement in both co-primary endpoints of (i) the number of patients achieving “Clear” or “Almost Clear” in the Investigator Global Assessment (IGA) scale and (ii) absolute mean reduction from baseline in inflammatory lesion count starting as early as Week 2, and continued through Week 12.
Epsolay also demonstrated a favorable safety and tolerability profile similar to vehicle.
The most common adverse reactions occurring in >1% of subjects treated with Epsolay and more frequently than in subjects treated with vehicle was application site erythema (2.3% vs. 0.9%), application site pain (2.3% vs. 0.9%), and application site pruritis (1.2% vs. 0.4%). Most subjects experienced adverse reactions that were mild or moderate in severity.
“Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans. Regretfully, rosacea patients are dissatisfied with the efficacy of current therapies,” stated Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel.
“The results from our Phase 3 studies showed statistically significant higher success in IGA compared with the vehicle, at every visit, and as early as at Week 2, as well as statistically significant higher reduction in absolute inflammatory lesion counts compared with the vehicle, at every visit, and as early as Week 2.
In addition, a quarter of Epsolay patients in both trials reached their treatment goals within a month, which is very encouraging.”
https://fda.einnews.com/pr_news/525964585/sol-gel-technologies-announces-fda-acceptance-for-filing-of-new-drug-application-for-epsolay-for-the-treatment-of-inflammatory-lesions-of-rosacea
