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news.Arcutis Pharmaceuticals, a privately held specialty pharmaceutical organization, has announced that the FDA has approved the new drug application of Acanya gel for the once-daily treatment of acne vulgaris in patients 12 years and older.
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Evaluated in clinical studies enrolling over 3,200 subjects with moderate to severe acne, Acanya Gel is said to be the only FDA-approved fixed combination antibiotic and benzoyl peroxide medication for once daily treatment of both non-inflammatory and inflammatory lesions of acne.
Bhaskar Chaudhuri, president and CEO of Arcutis Pharmaceuticals, 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.”