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Epsolay FDA Approval History

Last updated by Judith Stewart, BPharm on April 27, 2022.

FDA Approved: Yes (First approved April 22, 2022)
Brand name: Epsolay
Generic name: benzoyl peroxide
Dosage form: Cream
Company: Sol-Gel Technologies, Ltd.
Treatment for: Rosacea

Epsolay (benzoyl peroxide) is a topical oxidizing agent for the treatment of inflammatory lesions of rosacea in adults.

  • Rosacea is a chronic and recurrent skin condition characterized by redness, visible blood vessels, and inflammatory lesions on the cheeks, nose, chin or forehead.
  • The benzoyl peroxide contained in Epsolay is an oxidizing agent with bactericidal and keratolytic effects. The exact way in which Epsolay works in the treatment of rosacea is unknown.
  • Epsolay utilizes a proprietary technology to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile.
  • The FDA approval was supported by data from two Phase 3 randomized, double-blind clinical trials that evaluated the safety and efficacy of Epsolay compared to vehicle in 733 patients with inflammatory lesions of rosacea. After 12 weeks, in the patients treated with Epsolay, symptoms were reduced by nearly 70%, and 50% of the patients were 'clear' or 'almost clear'. In those who received vehicle, symptoms were reduced by 38-46%, and 38-46% of the patients reported 'clear' or 'almost clear'.
  • Epsolay cream is applied as a thin layer to the affected areas of skin once a day.
  • Epsolay warnings and precautions include severe hypersensitivity reactions, skin irritation/contact dermatitis, and photosensitivity reactions.
  • Common adverse reactions include application site reactions (pain, erythema, pruritis and edema).

Development timeline for Epsolay

DateArticle
Apr 25, 2022Approval FDA Approves Epsolay (benzoyl peroxide) Cream for the Treatment of Rosacea
Apr 27, 2021Sol-Gel Technologies Provides Update on FDA Review of Epsolay
Sep 10, 2020Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug Application for Epsolay (benzoyl peroxide) for the Treatment of Inflammatory Lesions of Rosacea

Further information

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