FDA Approves Cabtreo(TM) (Clindamycin Phosphate, Adapalene and Benzoyl Peroxide) Topical Gel for the Treatment of Acne Vulgaris in Patients Twelve Years of Age and Older

First and only FDA-approved fixed-dose, triple-combination topical treatment

LAVAL, QC / ACCESSWIRE / October 20, 2023 / Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC) ("Bausch Health") and its dermatology business, Ortho Dermatologics, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for CABTREO^TM (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, indicated for the topical treatment of acne vulgaris in patients twelve years of age and older. CABTREO is the first and only FDA-approved fixed-dose, triple-combination topical treatment for acne. CABTREO is expected to be available to patients in Q1 2024.

"With today's approval of CABTREO, millions of Americans who suffer from acne each year have a new triple-combination topical acne treatment," said Thomas J. Appio, Chief Executive Officer, Bausch Health. "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."

CABTREO offers three mechanisms of action, combining an antibiotic, retinoid and antibacterial, to provide a proven, safe and effective treatment.

"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," said Julie C. Harper, MD., Dermatology & Skin Care Center of Birmingham, Birmingham, AL. "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."

CABTREO Comprehensive Clinical Data

CABTREO was studied in two Phase 3 multicenter, randomized, placebo controlled clinical trials in 363 patients with acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving treatment success (2 grade reduction of the EGSS (evaluators global severity score) from baseline with an EGSS score of clear (0) or almost clear (1)).