FDA Approves Valeant's Onexton Gel for the Treatment of Acne Vulgaris

The FDA approved Valeant Pharmaceuticals International, Inc.’s Onexton Gel (clindamycin phosphate and benzoyl peroxide) 1.2%/3.75% for the once-daily treatment of comedonal and inflammatory acne in patients 12 and older.

"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 chief executive officer. "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. This continues to validate our output driven approach to R&D.  Valeant has already successfully launched Jublia (efinaconazole) 10%, Retin-A Micro (tretinoin gel) microsphere 0.08% and Luzu (luliconazole) 1 and we plan to launch Onexton in early 2015."

"Acne is a pervasive disease that, if left unchecked, can have significant impact for patients" said Joshua Zeichner, MD, Director of Cosmetic and Clinical Research, Department of Dermatology, Mount Sinai Hospital. "We encourage people with acne to visit a dermatologist or other healthcare professional for treatment. Onexton Gel is an effective topical medication, appropriate for patients with a wide range of acne and has a favorable tolerability profile."

Onexton Gel is the first and only FDA-approved fixed combination 1.2% clindamycin phosphate and 3.75% benzoyl peroxide medication for the once-daily treatment of comedonal and inflammatory acne. Onexton Gel has a favorable cutaneous tolerability profile and contains no surfactants, alcohol or preservatives. Onexton Gel has been studied extensively prior to its approval. In a pivotal trial with 498 patients with moderate to severe acne, efficacy was assessed at week 12. Onexton Gel reduced non-inflammatory lesions by a mean of 52 percent vs. 28 percent vehicle, for mean absolute reductions of 19 vs. 10, respectively. Onexton Gel also reduced inflammatory lesions by a mean of 60 percent vs. 31 percent vehicle, for mean absolute reduction of 16 vs. 8, respectively. In addition, the proportion of patients experiencing treatment success in the Onexton group was twice that of vehicle (35 percent vs. 17 percent). Treatment success was defined as at least two-grade improvement in the Evaluator Global Severity (EGS) score from baseline.

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