Valeant develops an acne drug with a low concentration of BPO combined with clindamycin

Sep 8 2009

One of the most widely prescribed drugs for acne vulgaris is benzoyl peroxide (BPO). However, at concentrations of 5-10%, BPO has the potential for skin irritation and dryness leading to poor patient compliance. Increasingly, BPO is combined with clindamycin in a fixed combination where the efficacy effects of the two ingredients are synergistic. Dermatologists have indicated that a formulation containing a low concentration of BPO combined with clindamycin would be a very welcome addition to their armamentarium of acne drugs.

Proprietary Formulation Optimization Process Produces Results

Acanya^® Gel (clindamycin phosphate 1.2% and BPO 2.5%) from Coria Laboratories, the newly expanded dermatology division of Valeant Pharmaceuticals North America, was developed through a formulation optimization process designed to deliver powerful results and favorable cutaneous tolerability. An in vitro human skin permeation study demonstrated that the levels of BPO (expressed as benzoic acid) seen with Acanya Gel were comparable to those achieved from higher concentration BPO (5%)-fixed combination products. And, by reducing the concentration of BPO from 5% to 2.5% the potential irritancy effect was reduced by 33% as demonstrated in a cumulative irritation study with 35 healthy subjects.

An extensive Phase III clinical program in over 2,800 patients with moderate to severe acne confirmed the powerful results and favorable cutaneous tolerability profile of Acanya Gel. Acanya Gel showed superior efficacy to the vehicle gel and both individual active ingredients in both inflammatory and noninflammatory lesions.

“Based on available data, Acanya Gel delivers levels of BPO into the skin comparable to the commercially available clindamycin-5% BPO gel products,” said one of the study’s authors, Dr. James Q. Del Rosso, Clinical Associate Professor (Dermatology) at the University of Nevada School of Medicine in Las Vegas and Director of the Dermatology Residency Program at Valley Hospital Medical Center, Las Vegas. “This is believed to be due to an optimization of vehicle formulation characteristics achieved by using a non-irritating level of propylene glycol as an in situ solubilizer of the BPO micro-particles, which are then capable of depositing in the follicular infundibulum after topical application.”

Formulation Constituents Influence Tolerability

“Acanya Gel is a unique and elegant aqueous gel formulation,” said Diana Chen, MD, Vice President of Medical Affairs for Coria Laboratories. “By eliminating surfactants, alcohol and preservatives, which are known skin irritants and reducing the concentration of BPO, local skin tolerability, and, therefore, patient compliance, may be improved. Acanya Gel is applied once daily,” continued Dr. Chen. “This too should help to increase compliance.”