Valeant announced that the Food and Drug Administration (FDA) has approved Onexton (clindamycin phosphate and benzoyl peroxide) Gel for the once-daily treatment of comedonal and inflammatory acne in patients aged ≥12 years old.

Onexton Gel was evaluated in patients with moderate to severe acne (n=498) for treatment efficacy at Week 12. Use of Onexton Gel reduced non-inflammatory lesions by an average of 52% vs. 28% vehicle, for mean absolute reductions of 19 vs. 10, respectively. Treatment with Onexton Gel also decreased inflammatory lesions by an average of 60% vs. 31%, for mean absolute reduction of 16 vs. 8, respectively. Treatment success was seen twice as much in the Onexton group vs. the vehicle group (35% vs. 17%).

RELATED: Topical Acne Treatments

Onexton Gel will be available in a 1.2%/3.75% strength and is surfactant-, alcohol-, and preservative-free. The product is expected to launch in early 2015.

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