Bausch Health has announced that the U.S. Food and Drug Administration (FDA) has approved IDP-126 (Cabtreo™) for the treatment of acne in patients aged 12 years and older.
IDP-126 (clindamycin phosphate 1.2%, adapalene 0.15%, and benzoyl peroxide 3.1%) is the first and only FDA-approved fixed-dose, triple-combination topical treatment for acne. It offers three mechanisms of action, combining an antibiotic, retinoid, and antibacterial, to provide a proven, safe, and effective treatment.
According to Thomas J. Appio, CEO of Bausch Health, “With today’s approval of CABTREO, millions of Americans who suffer from acne each year have a new triple-combination topical acne treatment. Acne treatment often requires using multiple products and dosing regimens, which can pose a number of challenges for patients. CABTREO has the potential to simplify dosing with a once daily topical acne treatment regimen.”
The approval of CABTREO comes after two Phase 3 multicenter, randomized, placebo controlled clinical trials including a total of 363 patients with acne were conducted. In both of these studies, all co-primary endpoints were met. This included absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving treatment success.
In the first study, 49.6% of participants achieved treatment success with CABTREO compared to 24.9% with vehicle. For the second study, a total of 50.5% of participants achieved treatment success with CABTREO compared to only 20.5% of those with vehicle.
Consider joining us in Miami Beach this Feb. 8-11, 2024 for our annual South Beach Symposium and ensure you remain up-to-date on the latest treatments and therapies in both medical and aesthetic dermatology.