The Food and Drug Administration (FDA) has approved Twyneo® (tretinoin 0.1% and benzoyl peroxide 3%) cream for the topical treatment of acne vulgaris in patients 9 years of age and older.

Twyneo is a fixed-dose combination of tretinoin 0.1%, a retinoid, and benzoyl peroxide 3%, a topical antibacterial. The formulation of Twyneo uses silica core shell structures to separately microencapsulate tretinoin crystals and benzoyl peroxide crystals enabling inclusion of the 2 active ingredients in the cream.

“Twyneo combines, for the first time, 2 of the most commonly used topical agents available for the treatment of acne into a single application,” said Hilary Baldwin, MD, Clinical Associate Professor of Dermatology, Rutgers Robert Wood Johnson School of Medicine, Medical Director, The Acne Treatment and Research Center and Past President of the American Acne and Rosacea Society. “Due to stability issues, these products don’t play well together, and we were never able to recommend even consecutive co-application of the 2 agents.”

The approval was based on data from 2 multicenter, double-blind, vehicle-controlled phase 3 trials (ClinicalTrials.gov Identifier:  NCT03761784 [Trial 1] and NCT03761810 [Trial 2]) that evaluated the efficacy and safety of Twyneo in 858 patients aged 9 years and older with moderate to severe acne. Patients were randomly assigned 2:1 to receive either Twyneo (n=571) or vehicle cream (n=287) once daily for 12 weeks.


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The co-primary end points for both trials included the proportion of patients who achieved at least a 2 grade reduction from baseline and “clear” (0) or “almost clear” (1) at week 12 (based on a 5-point Investigator’s Global Assessment scale), and an absolute change from baseline in inflammatory and non-inflammatory lesion counts at week 12.

Results from Trial 1 showed that 39.9% of patients treated with Twyneo achieved IGA treatment success compared with 14.3% in the vehicle group (difference from vehicle, 25.7%; 95% CI, 17.1-34.2). Compared with vehicle, Twyneo was associated with a statistically significant absolute change from baseline in inflammatory (-14.8 vs -21.6; difference from vehicle, -6.8; 95% CI, -9.1, -4.6) and non-inflammatory lesion counts (-19.8 vs -29.7; difference from vehicle, -9.9; 95% CI, -13.0, -6.8), respectively. 

Findings from Trial 2 showed 26.8% of patients treated with Twyneo achieved IGA treatment success vs 15.1% in the vehicle group (difference from vehicle, 11.6%; 95% CI, 3.6-19.7). Twyneo also demonstrated a greater absolute change from baseline in inflammatory (-16.2 vs -14.1; difference from vehicle, -2.1; 95% CI, -3.9, -0.4) and non-inflammatory lesion counts (-24.2 vs -17.4; difference from vehicle, -6.8; 95% CI, -9.9, -3.7) compared with vehicle.

As for safety, the most common adverse reactions occurred all at the application site and included pain, dryness, exfoliation, erythema, dermatitis, pruritus, and irritation. 

Twyneo is supplied in a 50g bottle with a pump.

References

  1. Sol-Gel Technologies announces FDA approval of Twyneo®. News release. Sol-Gel Technologies. Accessed July 27, 2021. https://www.globenewswire.com/news-release/2021/07/27/2269561/0/en/Sol-Gel-Technologies-Announces-FDA-Approval-of-TWYNEO.html
  2. Twyneo [package insert]. Whippany, NJ: Sol-Gel Technologies Inc.; 2021.