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Twyneo FDA Approval Status

FDA Approved: No
Brand name: Twyneo
Generic name: benzoyl peroxide and tretinoin
Dosage form: Cream
Company: Sol-Gel Technologies, Ltd.
Treatment for: Acne

Twyneo (benzoyl peroxide and tretinoin) is a fixed-dose combination of encapsulated benzoyl peroxide, 3%, and encapsulated tretinoin, 0.1%, cream for the treatment of acne vulgaris.

Tretinoin and benzoyl peroxide are widely prescribed separately as a combination treatment for acne; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. The microencapsulation technology used in Twyneo is designed to protect tretinoin from oxidative decomposition by benzoyl peroxide, thereby enhancing the stability of the active drug ingredients. The silica-based microcapsule is also designed to release the ingredients slowly over time to provide a favorable efficacy and safety profile.

Development Timeline for Twyneo

Dec  7, 2020Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug Application for Twyneo for the Treatment of Acne Vulgaris

Further information

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