Bausch Health and Ortho Dermatologics announced that a new drug application for the investigational IDP-126 gel has been accepted by the U.S. Food and Drug Administration. IDP-126 gel is a triplet combination therapy—comprising clindamycin 1.2%, adapalene 0.15%, and benzoyl peroxide 3.1%—designed to treat patients with acne vulgaris. In two placebo-controlled phase III trials, researchers found that the agent was capable of reducing the patients’ number of lesions and disease scores and helping them achieve clear or almost clear skin; in these trials, only mild to moderate adverse events were reported. The Prescription Drug User Fee Act action date for the application is October 20, 2023.
June 08, 2023