FDA accepts NDA for IDP 126 gel triple therapy to treat acne
Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, announced that the FDA has accepted the NDA for investigational IDP 126 (clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) Gel with a Prescription Drug User Fee Act (PDUFA) action date of October 20, 2023
If approved, IDP-126 has the potential to be the first of its kind fixed dose triple combination treatment for acne vulgaris.
“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,” said Thomas J. Appio, Chief Executive Officer, Bausch Health. “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.”
The NDA submitted for IDP 126 includes data from two successfully completed Phase III multicenter, randomized, placebo controlled clinical trials in 363 patients with acne vulgaris. Both studies met all coprimary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count and percentage of patients achieving treatment success (2 grade reduction of the EGSS with a final score of clear (0) or almost clear (1)). Both studies showed treatment-emergent adverse events were of mild to moderate severity.
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