FDA Set to Review Ortho Derm's Triple Combo Acne Gel

IDP-126 is a combination of an antibiotic, an antibacterial and a retinoid.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Ortho Dermatologics’ investigational IDP-126 (clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) Gel. The Prescription Drug User Fee Act (PDUFA) action date is set for October 20, 2023, according to a press release from parent company Bausch Health.

If approved, IDP-126 has the potential to be the first of its kind fixed dose triple combination treatment for acne vulgaris.

The NDA submitted for IDP-126 includes data from two successfully completed Phase 3 multicenter, randomized, placebo controlled clinical trials in 363 patients with acne vulgaris. Both studies met all co-primary 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.

Acne is the most common skin problem in the United States, which occurs when hair follicles become obstructed with sebum and skin cells, resulting in the formation of whiteheads, blackheads, or pimples to appear on the face, forehead, chest, upper back and shoulders.1,2 Up to 50 million Americans have acne. Depending on its severity, acne can cause emotional distress and scar the skin.