Valeant adds to dermatology portfolio

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Valeant Pharmaceuticals has received FDA approval for its Onexton Gel acne treatment, the fourth product approved in its medical dermatology business in the past twelve months. A fixed combination of 1.2% clindamycin phosphate and 3.75% benzoyl peroxide, the drug is for once-daily treatment of comedonal (non-inflammatory) and inflammatory acne in patients 12 and older. Valeantplans to launch the topical medication in early 2015.

Onexton follows hard on the launches of Jublia (efinaconazole) 10%, Retin-A Micro (tretinoin gel) microsphere 0.08%, and Luzu (luliconazole) 1% this year.

In pivotal trial, the drug reduced non-inflammatory lesions by a mean of 52% vs. 28% vehicle, and reduced inflammatory lesions by a mean of 60% vs. 31% vehicle. The proportion of patients experiencing treatment success in the Onexton group was twice that of vehicle (35% vs. 17%).

The new treatment contains no surfactants, alcohol or preservatives, and features a favorable cutaneous tolerability profile. Less than 1% of patients in the trial experienced a treatment-related adverse event.

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