On July 27, 2021, Sol-Gel Technologies announced that the US FDA has approved its innovative combination therapy Twyneo cream for the treatment of acne vulgaris (acne vulgaris) in adults and children aged 9 years and older
Twyneo is a fixed-dose compound topical cream containing 0.
1% tretinoin and 3% benzoyl peroxide.
Clinical trials have proved that it has significant efficacy and good safety characteristics
The press release pointed out that this is also the first fixed-dose combination of these two drugs approved by the FDA
Acne vulgaris is a common multifactorial skin disease that most commonly occurs in children and adolescents, affecting 80%-85% of adolescents, but it may also occur in adults
Skin lesions appear in areas where a large number of oil glands in the patient’s body, such as the face, chest, neck, and back, are inflammatory (papules, pustules, nodules) or non-inflammatory (acne) lesions
Acne can have a profound impact on the quality of life of patients
In addition to the major risk of permanent facial scars, it may also cause psychological stress, social fear, and decreased self-esteem
Tretinoin and benzoyl peroxide are widely used in the treatment of acne vulgaris, respectively.
If the effects of the two drugs can be used at the same time, the curative effect on patients will be stronger
However, because benzoyl peroxide can cause the degradation of tretinoin molecules, its combination therapy may reduce the efficacy of tretinoin
In order to solve this problem, Twyneo uses Sol-Gel's microencapsulation technology to encapsulate tretinoin and benzoyl peroxide in silica microcapsules.
This structure can stabilize tretinoin and benzoyl peroxide.
It is degraded by benzoyl peroxide and can slowly release the respective active pharmaceutical ingredients over time, resulting in good efficacy and safety characteristics
▲Sol-Gel's microencapsulated drug delivery technology (picture source: Sol-Gel's official website)
The approval is based on the positive results of two randomized, double-blind, excipient-controlled, multi-center Phase 3 clinical trials
Test data show that Twyneo has significant efficacy and well tolerated characteristics in patients with facial acne vulgaris 9 years and older
Note: The original text has been deleted
 Sol-Gel Technologies Announces FDA Approval of TWYNEO.
Retrieved July 28, 2021, from https://ir.