FDA approves IDP-126, first triple-combination gel for treatment of acne

Key takeaways:

• IDP-126 is comprised of clindamycin phosphate 1.2%, adapalene 0.15% and benzoyl peroxide 3.1%.
• The approval was supported by two phase 3 trials.

The FDA has approved IDP-126 for the treatment of acne in patients aged 12 years and older, Bausch Health announced in a press release.

The Oct. 20 approval makes IDP-126 (Cabtreo) the first and only fixed-dose, triple-combination topical treatment for acne, according to the press release.

“With today’s approval of Cabtreo, millions of Americans who suffer from acne each year have a new triple-combination topical acne treatment,” Thomas J. Appio, CEO of Bausch Health, said in the release.

“Acne treatment often requires using multiple products and dosing regimens, which can pose a number of challenges for patients. Cabreo has the potential to simplify dosing with a once daily topical acne treatment regimen,” Appio continued.

IDP-126 is comprised of clindamycin phosphate 1.2%, adapalene 0.15% and benzoyl peroxide 3.1%. Its approval was supported by data from two 12-week, multicenter, randomized, placebo-controlled phase 3 trials consisting of 363 patients with acne vulgaris.

The combined efficacy results from both trials resulted in approximately 50% of IDP-126-treated patients achieving treatment success, defined as a 2-grade reduction of severity according to the Evaluator’s Global Severity Score, and about 75% experienced a reduction in both inflammatory and noninflammatory lesions by week 12.

The most common adverse events of IDP-126, according to the studies, included application site reactions, pain, erythema, dryness, irritation, exfoliation and dermatitis.