The New Drug Application (NDA) for Epsolay® (benzoyl peroxide; Sol-Gel Technologies), an investigational treatment for rosacea, has been accepted for review by the Food and Drug Administration (FDA).

Epsolay is a topical cream that utilizes a patented technology process to encapsulate benzoyl peroxide 5% within silica-based microcapsules. Once applied, the medication then slowly migrates from the microcapsules to deliver an effective dose of benzoyl peroxide to the skin, while also reducing skin irritation.

The NDA includes data from 2 identical, multicenter, double-blind, phase 3 trials (NCT03448939 and NCT03564119) that compared the efficacy and safety of Epsolay to vehicle in 733 patients with papulopustular rosacea. Patients were randomized to receive either Epsolay or vehicle once daily for 12 weeks. The coprimary end points were the proportion of patients achieving “Clear” (0) or “Almost clear” (1) on the Investigator Global Assessment (IGA) scale and the absolute change in inflammatory lesion counts at week 12.

Findings from both trials showed that treatment with Epsolay led to statistically significant improvement based on the number of patients with an IGA score of 0/1. Patients treated with Epsolay also had an absolute mean reduction from baseline in inflammatory lesion counts as early as week 2, which continued through week 12.

As for safety, Epsolay was observed to have a favorable profile compared with vehicle. The most common adverse reactions occurring in >1% of patients treated with Epsolay were application site erythema (2.3% vs 0.9%), application site pain (2.3% vs 0.9%), and application site pruritus (1.2% vs 0.4%). 

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“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,” said Dr Alon Seri-Levy, CEO of Sol-Gel. “In addition, a quarter of Epsolay patients in both trials reached their treatment goals within a month, which is very encouraging.”

A Prescription Drug User Fee Act (PDUFA) target action date of April 26, 2021 has been set for this application.

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Sol-Gel Technologies announces FDA acceptance for filing of New Drug Application for Epsolay® for the treatment of inflammatory lesions of rosacea. Accessed September 11, 2020.