Cabtreo FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 30, 2023.
FDA Approved: Yes (First approved October 20, 2023)
Brand name: Cabtreo
Generic name: adapalene, benzoyl peroxide and clindamycin phosphate
Dosage form: Topical Gel
Company: Bausch Health Companies Inc.
Treatment for: Acne
Cabtreo (adapalene, benzoyl peroxide and clindamycin phosphate) is a triple-combination for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.
- Acne occurs when hair follicles become obstructed with sebum and skin cells, resulting in the formation of whiteheads, blackheads, or pimples on the face, forehead, chest, upper back and shoulders.
- Cabtreo contains three FDA-approved ingredients offering three mechanisms of action: adapalene (a retinoid), benzoyl peroxide (an antibacterial and anti-inflammatory agent), and clindamycin phosphate (a lincosamide antibacterial).
- Cabtreo was was studied in two Phase 3 multicenter, randomized, placebo controlled clinical trials.
- In Study 1, 49.6% of participants achieved treatment success with Cabtreo compared to 24.9% with vehicle. Mean percent reduction for inflammatory lesions was 75.7% (27.7 mean absolute reduction) vs. 59.6% (21.7 mean absolute reduction) with vehicle. Mean percent reduction for non-inflammatory lesions was 72.7% (35.4 mean absolute reduction) vs. 47.6% (23.5 mean absolute reduction) with vehicle.
- In Study 2, 50.5% of participants achieved treatment success with Cabtreo compared to 20.5% with vehicle. Mean percent reduction for inflammatory lesions was 80.1% (30.1 mean absolute reduction) vs. 56.2% (20.8 mean absolute reduction) with vehicle. Mean percent reduction for non-inflammatory lesions was 73.3% (35.2 mean absolute reduction) vs. 49.0% (22.0 mean absolute reduction) with vehicle. - Cabtreo is applied in a thin layer to the affected areas once daily.
- Warnings and precautions associated with Cabtreo include hypersensitivity reactions, colitis, photosensitivity reactions, skin irritation, and allergic contact dermatitis.
- Common adverse reactions include application site reactions, pain, erythema, dryness, irritation, exfoliation, and dermatitis.
Development timeline for Cabtreo
| Date | Article |
|---|---|
| Oct 20, 2023 | Approval FDA Approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel for the Treatment of Acne Vulgaris |
Further information
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