NAPSR NEWS: FDA approves Valeant’s ONEXTON™ Gel to treat Acne Vulgaris

Nov. 26, 2014 - PRLog -- Valeant Pharmaceuticals has received approval from the U.S Food and Drug Administration (FDA)  for ONEXTON™ Gel (clindamycin phosphate and benzoyl peroxide), 1.2%/3.75% for the once-daily treatment of Acne vulgaris in patients 12 and older.

"We are very pleased that the FDA has approved this new dual action medication that gives physicians and patients a new option for the topical treatment of acne vulgaris," said J. Michael Pearson, chairman and chief executive officer. "ONEXTON is the fourth product to be approved in our medical dermatology business in the past twelve months, three of which were conceived and developed entirely by Valeant's internal R&D team. This continues to validate our output driven approach to R&D.  Valeant has already successfully launched Jublia® (efinaconazole) 10%, Retin-A® Micro (tretinoin gel) microsphere 0.08% and Luzu (luliconazole) 1% and we plan to launch ONEXTON™ in early 2015."

"Acne is a pervasive disease that, if left unchecked, can have significant impact for patients" said Joshua Zeichner, MD and Director of Cosmetic and Clinical Research, Department of Dermatology, Mount Sinai Hospital. "We encourage people with acne to visit a dermatologist or other healthcare professional for treatment. ONEXTON™ Gel is an effective topical medication, appropriate for patients with a wide range of acne and has a favorable tolerability profile."

ONEXTON™ Gel is the first and only FDA-approved fixed combination 1.2% clindamycin phosphate and 3.75% benzoyl peroxide medication  for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne. Efficacy was assessed at week 12 in 498 patients with moderate to severe acne. According to clinical data, the gel, ‘‘reduced non-inflammatory lesions by a mean of 52% vs. 28% vehicle, for mean absolute reductions of 19 vs. 10, respectively’’ The overall success rate was defined as at least 2 grade improvement in the Evaluator Global Severity (EGS) score from baseline.

Acne vulgaris is a chronic skin disorder that affects up to 40 to 50 million people in the United States.

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