Galderma has announced the US launch of 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.
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.
Findings from both trials demonstrated that a greater proportion of patients treated with Twyneo met the co-primary efficacy endpoints achieving a statistically significant Investigator’s Global Assessment (IGA) treatment success and a statistically significant absolute change from baseline in inflammatory and non-inflammatory lesion counts at week 12 compared with vehicle.
As for safety, the most common adverse reactions (incidence at least 1%) are pain, dryness, exfoliation, erythema, dermatitis, pruritus and irritation (all at the application site).
Twyneo is supplied in a 50g bottle with a pump. The product is expected to be available in the second quarter of 2022.
“Effective prescription acne treatments currently involve multi-step regimens because there is rarely a single treatment option that addresses the multiple causes of the skin condition. These routines can often result in low adherence, especially among boys,” said Caroline Robinson, MD, FAAD, Founder of Tone Dermatology. “Twyneo Cream may help teens with acne, especially the boys, struggling with generic tretinoin or adhering to complex treatment routines, since it’s a once-daily, potent combination that can be used any time of day.”
The Company will also be providing the Galderma CAREConnect savings card to assist eligible patients.
Galderma launches Twyneo® cream, the first ever tretinoin and benzoyl peroxide combination to treat facial acne. News release. Galderma. Accessed March 25, 2022. https://prnmedia.prnewswire.com/news-releases/galderma-launches-twyneo-r-cream-the-first-ever-tretinoin-and-benzoyl-peroxide-combination-to-treat-facial-acne-848372963.html