Bausch Health announces FDA approves Cabtreo in Acne Vulgaris

Bausch Health and its dermatology business, Ortho Dermatologics, announced that the FDA has approved the New Drug Application for CABTREO 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. 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. Combined efficacy results for both trials for CABTREO achieved approximately 50% treatment success and approximately 75% reduction in both inflammatory and noninflammatory lesions at Week 12.