LAUNCH ALERT: FDA Approves IDP-126 Gel for Acne Vulgaris
The once-daily triple-combination topical acne treatment is approved for use in patients 12 years and older
By Dermsquared Editorial Team | October 25, 2023
Dr James Q Del Rosso announces the launch of IDP-126 gel, discussing its unique mechanism of action, efficacy, tolerability profile, and dosing
Bausch Health Companies Inc. and Ortho Dermatologics have announced FDA approval for IDP-126 (clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) topical gel, indicated for the treatment of acne vulgaris in patients 12 years and older. This approval marks the only FDA-approved fixed-dose, triple-combination topical treatment for acne.
IDP-126 topical gel was studied in two Phase 3 multicenter, randomized, placebo-controlled clinical trials, both meeting all coprimary efficacy endpoints. In Study 1, participants treated with IDP-126 saw a mean percent reduction for inflammatory lesions of 75.7% vs 59.6% vs those treated with vehicle and a mean percent reduction for noninflammatory lesions of 72.7% vs 47.6% with vehicle.
In Study 2, participants treated with IDP-126 saw a mean percent reduction of 80.1% for inflammatory lesions vs 56.2% for those treated with vehicle and a mean percent reduction of 73.3% for noninflammatory lesions vs 49.0 with vehicle.
The most common adverse reactions (>1%) were application site reactions, pain, erythema, dryness, irritation, exfoliation, and dermatitis.
IDP-126 topical gel works by combining 3 mechanisms of action via an antibiotic, retinoid, and antibacterial. It is expected to be available to patients in Q1 2024