FDA Accepts New Drug Application for Sol-Gel Rosacea Topical

A new topical for rosacea featuring 5% encapsulated benzoyl peroxide moves one step closer to market as the FDA accepts its NDA.

Dreamstime M 178178080

The U.S. Food and Drug Administration (FDA) has accepted Sol-Gel Technologies' New Drug Application (NDA) for Epsolay (benzoyl peroxide).

Epsolay is a topical cream that treats inflammatory lesions of rosacea. It contains 5% encapsulated benzoyl peroxide. It utilizes a patented technology process to encapsulate benzoyl peroxide within silica-based microcapsules, to create a barrier between the medication and the skin. The slow migration of medication from the microcapsules is designed to deliver an effective dose of benzoyl peroxide to the skin, while reducing the ability of benzoyl peroxide to induce skin irritation, such as erythema, burning and stinging. Epsolay has the potential to be first FDA-approved single-agent benzoyl peroxide prescription drug product on the market.

“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,” said Alon Seri-Levy, CEO 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.”

More in News