FDA To Review New Drug Application for Triple-Combination IDP-126 Gel


The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational IDP-126 gel for the treatment of acne vulgaris.

This novel, triple-combination drug combines an antibiotic, an antibacterial, and a retinoid and consists of clindamycin 1.2%, adapalene 0.15%, and benzoyl peroxide 3.1%. According to Bausch Health and its dermatology business, Ortho Dermatologics, “IDP-126 has the potential to be the first-of-its-kind fixed-dose triple combination treatment for acne vulgaris.”

The NDA is supported by results from two phase 3 multicenter, randomized, placebo-controlled clinical trials which evaluated 363 patients with acne vulgaris. Both of these studies met all co-primary efficacy endpoints including absolute change from baseline in inflammatory lesion count and non-inflammatory lesion count and the percentage of patients achieving treatment success.

Thomas J. Appio, CEO of Bausch Health, has stated, “In requesting approval from the FDA, we are hopeful that we may be able to bring a first-of-its-kind triple-combination acne treatment to the millions of Americans who suffer from acne each year. The treatment of acne can be challenging and may often require multiple therapies. With the potential of a triple-combination product, we believe IDP-126, if approved, could not only help alleviate the existing burden of treatment but also potentially help patient outcomes.”

IDP-126 has been the topic of much discussion in recent months, with many dermatologists eager to see it become available to their patients. LiVDerm Advisory Board Member, Leon H. Kircik, MD has previously shared his own excitement, stating, “It’s going to be a very, very unique product that we expect to hit every aspect of acne treatment.”

The Prescription Drug User Fee Act action date has been set for October 20, 2023.


Sign up to receive updates on educational opportunities, complimentary content, exclusive discounts, and more.