FDA approves Twyneo to treat acne vulgaris – Galderma + Sol-Gen Technologies

Sol-Gel Technologies, Ltd. announced that the FDA has approved its first proprietary drug product, Twyneo (tretinoin/benzoyl peroxide) cream, 0.1%/3%, indicated for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older.

Twyneo uses Sol-Gel’s patented technology to entrap tretinoin, a retinoid, and benzoyl peroxide within silica-based microcapsules to stabilize tretinoin from being degraded by benzoyl peroxide and to slowly release each of the active drug ingredients over time to provide a favorable efficacy and safety profile. Twyneo is patent protected until 2038.

Sol-Gel has partnered with Galderma to commercialize Twyneo in the U.S. Sol-Gel expects to receive a regulatory milestone payment in conjunction with this approval and retains the option to regain U.S. commercialization rights five years following first commercialization in the U.S.