Arcutis Pharmaceuticals, a privately held specialty pharmaceutical organization focusing in medical dermatology, announced 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, 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 US 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 US patents and has pending patent applications.
Arcutis is a new medical dermatology-focused, specialty pharmaceutical organization created with the goal of developing improved prescription medications that patients love to use.