FDA Approves Patented Gel for Treating Acne
|Written by Gene Quinn
Patent Attorney & Founder of IPWatchdog
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Posted: Nov 21, 2008 @ 9:22 am
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.
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.
About the Author
Gene Quinn is a US Patent Attorney, law professor and the founder of IPWatchdog.com. He is also a principal lecturer in the top patent bar review course in the nation, which helps aspiring patent attorneys and patent agents prepare themselves to pass the patent bar exam. Gene started the widely popular intellectual property website IPWatchdog.com in 1999, and since that time the site has had many millions of unique visitors. Gene has been quoted in the Wall Street Journal, the New York Times, the LA Times, USA Today, CNN Money, NPR and various other newspapers and magazines worldwide. He represents individuals, small businesses and start-up corporations. As an electrical engineer with a computer engineering focus his specialty is electronic and computer devices, Internet applications, software and business methods.