FDA approves gel treatment for acne

December 2, 2014

The Food and Drug Administration has approved Onexton Gel (clindamycin phosphate and benzoyl peroxide 1.2 percent/3.75 percent, Valeant Pharmaceuticals) for the once-daily treatment of comedonal and inflammatory acne in patients 12 and older.

The Food and Drug Administration has approved Onexton Gel (clindamycin phosphate and benzoyl peroxide 1.2 percent/3.75 percent, Valeant Pharmaceuticals) for the once-daily treatment of comedonal and inflammatory acne in patients 12 and older.

According to a Valeant news release, Onexton Gel “is the first and only FDA-approved fixed combination 1.2 percent clindamycin phosphate and 3.75 percent benzoyl peroxide medication for the once-daily treatment of comedonal and inflammatory acne.” The release goes on to say that at week 12 of a pivotal trial involving 498 patients with moderate to severe acne, Onexton reduced non-inflammatory lesions by a mean of 52 percent versus 28 percent vehicle and reduced inflammatory lesions by a mean of 60 percent versus 31 percent vehicle.

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The company also noted that serious side effects, including colitis and allergic reactions, have been reported with the use of combination clindamycin/benzoyl peroxide products.

News of the approval met with measured responses from two veteran dermatologists.

“Combination products for acne have been available since the first one (Benzamycin) was approved in 1984, and there are several BP/clinda combos as well as an adapalene/BP (Epiduo) and a tretinoin/clinda combo (Ziana),” says Elaine Siegfried, M.D., professor of pediatrics and dermatology at Saint Louis University Health Sciences Center. “In general, efficacy trials for all these products are better than placebo, but the placebo response is surprisingly and consistently high for all acne trials. So most products in this category work equally well.”

Dr. Siegfried adds that while it’s difficult to predict which product a patient will like, their typical top priority is out-of-pocket cost.

“And prescription benefits are increasingly limited for all acne products, especially branded ones,” she says.

Ronald Wheeland, M.D., Columbia, Mo., noted that while the combination that comprises Onexton is newly approved, the individual ingredients have been available for a long time.

“The FDA has had a love-hate relationship with any combination drug, whether it’s oral or topical, so from the standpoint of them giving approval for a dual product, [the approval of Onexton] is indeed new but not earthshaking,” he tells Dermatology Times. “I find of particular interest the fact that one of the problems with giving clindamycin orally-since it has been around for quite awhile-was that it caused colitis in a large number of patients who took it, and sometimes the colitis persisted even after the drug was stopped. For that reason, I believe, the FDA took it off the market for the oral treatment of acne and restricted its use to serious internal infections. However, as [Valeant’s] own news release admits, one of the serious side effects with Onexton included colitis, making me wonder if this might limit its usefulness.”

Valeant officials say they plan to launch Onexon in early 2015.