Arcutis gets FDA appro for Acanya acne gel

California, USA-based Arcutis Pharmaceuticals, a privately-held specialty pharmaceutical organization focusing in medical dermatology, has received approval for the New Drug Application for Acanya Gel (clindamycin phosphate and benzoyl peroxide) for the once-daily treatment of acne vulgaris in patients 12 years and older from the Food and Drug Administration.

Evaluated in clinical studies enrolling over 3,200 subjects with moderate-to-severe acne, Acanya is now the only FDA-approved fixed combination antibiotic and benzoyl peroxide medication for once-daily treatment of both non-inflammatory and inflammatory lesions of acne.

Chief executive Bhaskar Chaudhuri said: "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."