FDA Approves ONEXTON Gel For Acne Vulgaris

Valeant Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval for ONEXTON Gel (clindamycin phosphate and benzoyl peroxide, 1.2%/3.75%), for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne in patients 12 and older.

In a pivotal trial with 498 patients with moderate to severe acne, ONEXTON Gel reduced noninflammatory lesions by a mean of 52% vs. 28% vehicle and reduced inflammatory lesions by a mean of 60% vs. 31% vehicle. In addition, the proportion of patients experiencing treatment success—defined as at least two grade improvement in the Evaluator Global Severity (EGS) score from baseline—was twice that of vehicle (35% vs. 17%).

In the controlled clinical trial, less than 1% of patients experienced a treatment-related adverse event. The most common adverse events were: burning sensation (0.4%), dermatitis contact (0.4%), pruritus (0.4%) and rash (0.4%). No patient discontinued treatment due to any adverse event.

“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 CEo of Valeant. “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. Valeant has already successfully launched Jublia (efinaconazole) 10%, Retin-A Micro (tretinoin gel) microsphere 0.08% and Luzu (luliconazole) 1%. We plan to launch ONEXTON™ in early 2015."

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