July 27, 2021
The U.S. FDA has approved Twyneo® (tretinoin/benzoyl peroxide) cream, manufactured by Sol-Gel Technologies. The product is indicated as a topical treatment for acne vulgaris in patients who are at least nine years of age. It is the first FDA-approved fixed-dose combination of tretinoin and benzoyl peroxide.
Acne vulgaris, more commonly called acne, affects as many as 50 million people in the United States. It can lead to lesions on various parts of the body, including the face, chest, neck, and back. For some patients, it can be painful and lead to permanent scarring as well as profound negative effects on social life and self-esteem.
Although both commonly prescribed to treat acne, tretinoin and benzoyl peroxide can be difficult to use in combination because the benzoyl peroxide degrades the tretinoin and reduces its effectiveness. Twyneo uses a proprietary technology that allows both ingredients to be included in the same cream by encapsulating each one with silicon dioxide that preserves tretinoin’s effectiveness.
Recommended dosing with Twyneo is a thin layer applied to affected areas once daily, avoiding contact with the eyes, lips, paranasal creases, and mucous membranes. Individuals who apply the cream should wash their hands following its application.
Launch and pricing plans are not yet available.