FDA Approves IDP-126 (Cabtreo), First Triple-Combination Drug for Acne

The US Food and Drug Administration (FDA) has approved clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (Cabtreo), formerly known as IDP-126, for the treatment of acne vulgaris in patients aged 12 years old and older.

Announced on October 20, 2023, the indication granted to Bausch Health and Ortho Dermatologics marks the triad treatment of clindamycin phosphate 1.2%, benzoyl peroxide 3.1% and adapalene gel 0.15% as the first fixed-dosed, triple-combination treatment approved by the FDA for patients with acne. What’s more, its application was supported by robust clinical efficacy data that which clinicians believe support its use as a first-option treatment for patients.

“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, of the Dermatology & Skin Care Center of Birmingham. “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.”

The approved New Drug Application (NDA) was supported by findings from a pair of phase 3 multicenter, randomized, placebo-controlled clinical trials including 363 patients with acne vulgaris. Investigators reported that both studies achieved their co-primary efficacy endpoints, including:

• Absolute change in inflammatory lesion count from baseline.
• Absolute change from baseline in non-inflammatory lesion count and percentage of patients achieving treatment success from baseline.
• A ≥2-grade reduction in Evaluator’s Global Severity Score (EGSS) from baseline, with a final score of 0 or 1, indicating clear or almost clear skin.

Investigators additionally observed that treatment-emergent adverse events (TEAEs) were mild to moderate in severity. Further post-hoc analysis data from a phase 2 study was presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting in New Orleans this March, including 394 study participants aged 10 – 17 years old who received ≥1 dose of IDP-127 and were evaluated ≥1 time for safety post-baseline.

Investigators led by Lawrence Eichenfield, MD, professor in the departments of dermatology and pediatrics at the University of California, San Diego School of Medicine and HCPLive Editorial Advisory Board member, reported that an approximate 10-fold greater rate of patients receiving IDP-126 achieved treatment success per EGSS score improvement of ≥2 (55.8%) than those receiving vehicle (5.7%).

Eichenfield and colleagues additionally observed that a significantly greater rate of inflammatory lesions (78.3%) and non-inflammatory lesions (70.0%) were reduced in treated patients versus vehicle (45.1% and 37.6%, respectively). Among the most commonly observed TEAEs in the IDP-126 arm were application site dryness and pain.

As a triple-combination treatment, IDP-126 is designed to treat the inflammation, bacteria and follicular hyperkeratinization associated with moderate to severe cases of acne, Hilary Baldwin, MD, medical director of the Acne Treatment & Research Center in New York, told HCPLive this summer.

In an interview during the Maui Derm 2023 NP + PA Summer Conference in Colorado Springs this June, Baldwin suggested an FDA-approved IDP-126 would become a first-line acne treatment option—save for theoretically, instances of treating pregnant patients.

“I think a better question is, ‘Where does it not fit?’” Baldwin said at the time. “The phase 2 and 3 trials showed excellent efficacy—not only compared to vehicle, but also compared to the (double-combination therapies), the one’s we’ve been relying on all these years. I think it’s going to blow me away.”

References

1. ^{FDA approves Cabtreotm (clindamycin phosphate, adapalene and benzoyl peroxide) topical gel for the treatment of acne vulgaris in patients twelve years of age and older. – Bausch Health Companies Inc. October 20, 2023. Accessed October 21, 2023. https://ir.bauschhealth.com/news-releases/2023/10-20-2023.}
2. ^{Smith T. Triple-Combination Topical Treatment Effective for Acne in Pediatric Participants. HCPLive. Published March 29, 2023. https://www.hcplive.com/view/triple-combination-topical-treatment-effective-acne-pediatric-participants}
3. ^{Kunzmann K. Hilary Baldwin, MD: IDP-126 May Change Acne Management. HCPLive. Published June 24, 2023. https://www.hcplive.com/view/hilary-baldwin-idp-126-may-change-acne-management}