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BENZEFOAM Emollient Foam Demonstrates Significant Reduction in Propionibacterium acnes in Study Presented at the Fall Clinical Dermatology Conference

As an acne treatment, benzoyl peroxide works primarily through its potent antibacterial effect. In previous studies of patients with P. acnes colonization on their faces, benzoyl peroxide has demonstrated a 1.0 to 2.0 logarithmic reduction (equivalent to a 90% to 99% reduction) of P. acnes. Prior to this study, no data was available that specifically examined P. acnes reduction on the back with benzoyl peroxide. This five-week, open-label, crossover study included 20 subjects (>18 years old) with P. acnes colonization on their backs (>10,000 colonies per cm²).

The study results demonstrated that total P. acnes colony counts were reduced by >99% after 2 weeks of treatment with BenzEFoam ; P. acnes were reduced 1.9 log after one week of treatment and by 2.1 log after two weeks of treatment with BenzEFoam . In contrast, the benzoyl peroxide 8% wash did not reduce P. acnes counts at all after two full weeks of treatment.

"The foam formulation of benzoyl peroxide clearly was effective in reducing P. acnes counts on the back to the level associated with a therapeutic effect when it was applied in our study center," said Dr. Leyden.

"BenzEFoam Emollient Foam is effective in reducing P. acnes on the back and is easy to spread over broad surface areas when acne presents on the chest, back, and shoulders," said Doug Abel, General Manager of Onset Therapeutics. "Wash-off formulations of benzoyl peroxide are commonly utilized for the treatment of acne on the trunk, due to patient convenience of application in the shower. However, the results of this study may cause a clinician to reconsider that approach and, in turn, increase their use of a leave-on treatment, such as BenzEFoam , which is specifically formulated for the treatment of body acne."

Both treatments were well tolerated by the study subjects. Neither treatment caused skin dryness, redness, scaling, or burning and neither treatment resulted in any patients discontinuing from the study.

BenzEFoam is indicated for the topical treatment of mild to moderate acne vulgaris and was designed for patients experiencing acne symptoms on their backs, shoulders, and chests. This study was supported by a grant from Onset Therapeutics.

About Acne

Acne vulgaris is a common skin disease, affecting 40 to 50 million Americans. Approximately 50% of all acne patients have both facial and non-facial acne symptoms. In the U.S. in the past year, more than five million patients with acne sought treatment from a physician, resulting in over 17 million prescriptions filled, according to data from Verispan and IMS.

Indication and Important Safety Information for BenzEFoam Emollient Foam

BenzEFoam (benzoyl peroxide) 5.3% Emollient Foam is indicated for use in the topical treatment of mild to moderate acne vulgaris. BenzEFoam Emollient Foam should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product. Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy. When using this product, avoid unnecessary sun exposure and use a sunscreen. BenzEFoam, like all benzoyl peroxide containing products, may bleach hair or colored fabrics.

About Onset Therapeutics

Onset Therapeutics is a specialty pharmaceutical company focused on the development and commercialization of dermatology products formulated with the Company's innovative proprietary topical formulation technologies and unique delivery systems. The Company utilizes its novel DELEVO Foam Technology that is designed to deliver enhanced penetration of proven active ingredients in cosmetically elegant, hydrating formulations with the goal of enhancing patient compliance.

For more information, please visit www.BenzEFoam.com.

For Onset Therapeutics
Mary Theriault, 401-762-2000 ext. 21
mtheriault@onsettx.com