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FDA Approves Acanya

FDA Approves Acanya

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Nov 20, 2008 - Arcutis Pharmaceuticals, a privately held specialty pharmaceutical organization focusing in medical dermatology, announced today 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.

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%).

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.

Contact: Arcutis Pharmaceuticals
David Mullarkey, 650-517-5308
Vice President, Marketing
david.mullarkey@arcutis.com

Posted: October 2008

Acanya (benzoyl peroxide and clindamycin phosphate) FDA Approval History

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