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FDA Approves Onexton Gel for Treatment of Acne Vulgaris

First fixed-combination clindamycin/benzoyl peroxide medication for once-daily treatment

The FDA has given the green light to Onexton Gel (clindamycin phosphate and benzoyl peroxide, Valeant Pharmaceuticals International, Inc.), 1.2%/3.75%, for the once-daily treatment of noninflammatory (comedonal) and inflammatory acne in patients 12 years of age and older.

Acne vulgaris is a common skin disorder that affects 40 million to 50 million people in the U.S.

Onexton Gel is the first FDA-approved fixed-combination 1.2% clindamycin phosphate and 3.75% benzoyl peroxide medication for the once-daily treatment of noninflammatory and inflammatory acne. The product has a favorable cutaneous tolerability profile and contains no surfactants, alcohol, or preservatives.

The efficacy of Onexton Gel was studied in a pivotal trial involving 498 patients with moderate-to-severe acne. At week 12, Onexton Gel reduced noninflammatory lesions by a mean of 52% compared with a reduction of 28% in subjects given vehicle, for mean absolute reductions of 19 vs. 10, respectively. Onexton Gel also reduced inflammatory lesions by a mean of 60% compared with 31% for vehicle, for mean reductions of 16 vs. 8, respectively. In addition, the proportion of patients experiencing treatment success in the Onexton group was twice that in the vehicle group (35% vs. 17%, respectively). Treatment success was defined as at least a two-grade improvement in the Evaluator Global Severity (EGS) score from baseline.

Less than 1% of patients experienced a treatment-related adverse event (AE). The most common treatment-emergent and treatment-related AEs associated with active treatment included a burning sensation, contact dermatitis, pruritus, and rash (each 0.4%). No patient receiving Onexton Gel had their treatment discontinued because of an AE.

Serious AEs, including colitis and allergic reactions, have been reported with the use of combination clindamycin/benzoyl peroxide products. Patients should stop using Onexton Gel and should contact their physicians immediately if they have severe watery or bloody diarrhea, or if they experience severe itching; swelling of the face, eyes, lips, tongue, or throat; or difficulty breathing.

Source: Valeant Pharmaceuticals; November 25, 2014.


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