FDA Approves Patented Gel for Treating Acne

Arcutis Pharmaceuticals, a privately held specialty pharmaceutical organization focusing in medical dermatology, announced yesterday that the United States Food and Drug Administration (FDA) has approved the new drug application (NDA) of Acanya Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) for the once-daily treatment of acne vulgaris in patients 12 years and older. Evaluated in clinical studies enrolling over 3,200 subjects with moderate to severe acne, Acanya Gel is the only FDA-approved fixed combination antibiotic and benzoyl peroxide medication for once daily treatment of both non-inflammatory and inflammatory lesions of acne.

“We are very pleased to announce the FDA’s approval of Acanya Gel,” said Bhaskar Chaudhuri, Ph.D., President and Chief Executive Officer of Arcutis Pharmaceuticals. “Formulated in an aqueous-based, alcohol-free gel, Acanya was optimized to provide enhanced bioavailability of benzoyl peroxide, creating an effective and well tolerated product for patients. In pivotal clinical trials, Acanya Gel demonstrated synergistic efficacy superior to the vehicle gel and either clindamycin or benzoyl peroxide alone, while demonstrating excellent tolerability and no reports of application site dryness,” said Dr. Chaudhuri.

Acne vulgaris is a common skin disorder that affects about 85 percent of people at some point in their lives. In the past year, more than five million patients with acne in the U.S. sought treatment from a physician, resulting in over 17 million prescriptions filled, according to data from Verispan and IMS.

Acanya Gel is protected by two U.S. Patents and has pending patent applications. Full prescribing information for Acanya Gel can be obtained at www.arcutis.com or www.AcanyaGel.com.

About Arcutis Pharmaceuticals

Arcutis is a new medical dermatology-focused, specialty pharmaceutical organization created with the goal of developing improved prescription medications that patients love to use. Emerging as an independent entity from one of the world’s leading prescription dermatologic product development companies, Arcutis is leveraging over 30 years of expert insights and experience in topical product development. With its focus on superior product performance, Arcutis is committed to supporting dermatologists and their practices through greater patient satisfaction with improved therapies. Arcutis Pharmaceuticals is based in Redwood City, California, and is a division of Dow Pharmaceutical Sciences, Inc. For more information, please visit www.arcutis.com.


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One comment so far.

  • [Avatar for Sanford Furnas]
    Sanford Furnas
    April 22, 2011 08:40 am

    Unfortunately, there are more severe forms of acne with nodules that can cause serious scarring. The chances of scarring increase as the acne severity increases. To understand scars, you need to understand acne.Acne scars can seem like double punishment first you had to deal with the pimples, now you have marks as a reminder. The best way to control acne scars is to get treatment soon after the acne appears to prevent further severe acne and more scarring.