New Studies Examine Bioavailability and Low Irritancy Potential of a Fixed Combination Clindamycin Phosphate (1.2%) and Low Concentration (2.5%) Benzoyl Peroxide Gel for Treatment of Moderate to Severe Acne Vulgaris
FT. WORTH, Texas-(Business Wire)-September 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.”
About Acne Vulgaris
Acne vulgaris is a common skin disorder affecting 40 to 50 million Americans, or approximately 85 percent of people at some point in their lives. The disorder is thought to be caused by overproduction of sebum, a normal oily substance on the skin surface, combined with skin cells abnormally shed from the hair follicle, and skin bacteria, Propionibacterium acnes, resulting in inflammation in the skin in the form of acne
About Acanya Gel
Acanya Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. In controlled clinical trials, the following application-site adverse reactions occurred in less than 0.2% of patients treated with Acanya Gel: application-site pain (0.1%), application-site exfoliation (0.1%), and application-site irritation (0.1%). Patients are advised to avoid applying Acanya Gel in mouth, eyes, or nose or on lips, and to minimize sun exposure following application. Acanya Gel is the only FDA-approved fixed combination antibiotic and benzoyl peroxide (BPO) medication for once-daily treatment of both non-inflammatory and inflammatory lesions of acne. More information about Acanya® Gel and Important Safety Information can be obtained at www.AcanyaGel.com.
About Coria Laboratories
Coria Laboratories is the dermatology division of Valeant Pharmaceuticals North America, a subsidiary of Valeant Pharmaceuticals International.
About Valeant
Valeant Pharmaceuticals International (NYSE: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology and dermatology. More information about Valeant can be found at www.valeant.com.
FORWARD-LOOKING STATEMENTS:
This press release contains forward-looking statements, including, but not limited to, statements regarding the efficacy, tolerability and favorable safety profile of Acanya Gel and the potential for increased patient compliance. These statements are based upon the current expectations and beliefs of the management of Valeant Pharmaceuticals International and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the possibility that some information regarding tolerability and efficacy may not be apparent even in well designed clinical trials and other risks and uncertainties discussed in Valeant’s annual report on Form 10-K for the year ended December 31, 2008 and other filings with the SEC. Valeant wishes to caution the reader that these factors are among the factors that could cause actual results to differ materially from the expectations described in the forward-looking statements. Valeant also cautions the reader that undue reliance should not be placed on any of the forward-looking statements, which speak only as of the date of this release. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this release or to reflect actual outcomes.
Full prescribing information for Acanya Gel can be obtained at www.AcanyaGel.com.
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