The topical gel is the first and only FDA-approved triple-combination, fixed-dose topical treatment for acne, and is set to be available in the first quarter of 2024, according to Bausch Health Companies Inc.
On Friday, October 20, 2023, the FDA approved IDP-126 topical gel (clindamycin phosphate 1.2%, adapalene 0.15% and benzoyl peroxide 3.1%) (CABTREO; Bausch) for the treatment of acne vulgaris in pediatric patients 12 years and up, according to a press release from Bausch Health Companies Inc.
Set to be available to patients in the first quarter of 2024, IDP-126 is the first and only fixed-dose, triple-combination topical treatment for acne that is approved by the FDA. Antibiotic, retinoid, and antibacterial are 3 combined mechanisms of action provided by IDP-126.
“While most acne treatments currently available utilize multiple therapies and regimens, we are excited to see that the triple combination in [IDP-126] has resulted in significant treatment success and reduction in both the inflammatory and noninflammatory lesions typically associated with acne,” said Julie C. Harper, MD, Dermatology & Skin Care Center of Birmingham, Birmingham, Alabama, in the news release. “With the approval of [IDP-126], physicians can now offer patients an acne treatment that has the potential to be a simple, once daily dosing option.”
The FDA approval of prescription IDP-126 was supported by a pair of phase 3 randomized, placebo-controlled, multicenter clinical trials, which featured 363 patients with acne vulgaris. Absolute change from baseline in lesion count, percentage of patients achieving treatment success, and absolute change from baseline in noninflammatory lesion count were co-primary outcomes met in each study. Treatment success was defined as a 2-grade reduction of the evaluators global severity score (EGSS) from baseline with an EGSS score of clear (0) or almost clear (1).
Study 1 demonstrated that 49.6% of individuals achieved treatment success with IDP-126 compared to 24.9% vehicle. For inflammatory lesions, mean percent reduction was 75.7% (27.7 mean absolute reduction) with IDP-126 compared to 59.6% (21.7 mean absolute reduction) with vehicle. For noninflammatory lesions, a 72.7% mean percent reduction was observed for IDP-126-treated individuals compared to 47.6% for vehicle-treated patients (35.4 vs 23.5 mean absolute reduction, respectively).
In the second study, 50.5% achieved treatment success with IDP-126 vs 20.5% with vehicle. The treatment demonstrated an 80.1% mean percent reduction for inflammatory lesions compared to 56.2% vehicle (30.1 mean absolute reduction vs 20.8 mean absolute reduction, respectively.) The mean percent reduction for noninflammatory lesions observed in IDP-126-treated patients was 73.3% compared to 49.0% in vehicle-treated individuals (35.2 vs 22.0 mean absolute reduction, respectively). .
Application site reactions, erythema, dryness, pain, irritation, exfoliation, and dermatitis were the most common adverse reactions (occurring in >1% of the CABTREO group and greater than the vehicle group), Bausch stated in the news release.
FDA approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) topical gel for the treatment of acne vulgaris in patients twelve years of age and older. Bausch Health Companies Inc. Press release. October 20, 2023. Accessed October 20, 2023. https://ir.bauschhealth.com/news-releases/2023/10-20-2023