Valeant adds to dermatology portfolio
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.