Triple-combination acne gel set for FDA review

A new gel for treating acne vulgaris is set to undergo FDA review with the agency’s acceptance of a new drug application for investigational IDP-126, according to a press release from Bausch Health.

The IDP-126 gel, a product of Bausch Health’s dermatology business, Ortho Dermatologics, has potential to be a first-of-its-kind fixed-dose, triple-combination acne vulgaris treatment, according to the release. It is a combination of an antibiotic, an antibacterial and a retinoid: 1.2% clindamycin, 3.1% benzoyl peroxide and 0.15% adapalene, respectively.

A triple-combination product such as IDP-126 could “alleviate the existing burden of treatment,” in that treating acne often requires the use of multiple therapies and can be challenging, Thomas J. Appio, CEO of Bausch Health, said in the release.

An FDA Prescription Drug User Fee Act date for the new drug application for IDP-126 is Oct. 20.

Included in the application are data from two phase 3 multicenter, randomized, placebo-controlled clinical trials involving 363 acne vulgaris patients. Both phase 3 studies met all co-primary efficacy endpoints, which included absolute changes from baselines in inflammatory and non-inflammatory lesion counts, as well as percentage of patients successfully treated, according to the release.

Treatment-emergent adverse events were of mild to moderate severity in both phase 3 studies, according to the release.

As Healio previously reported, in a post-hoc analysis, patients aged 9 to 17 years who used IDP-126 in a phase 2 trial reported more improvements to their quality of life in nearly all acne-specific domains compared with patients who used other gels.