FDA Approves Triple Combination IDP-126 (Cabtreo™) for Acne 

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.

“While most acne treatments currently available utilize multiple therapies and regimens, we are excited to see that the triple combination in CABTREO has resulted in significant treatment success and reduction in both the inflammatory and noninflammatory lesions typically associated with acne. With the approval of CABTREO, physicians can now offer patients an acne treatment that has the potential to be a simple, once daily dosing option.”

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.


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