FDA Approves Onexton Gel for Acne

The FDA approved Valeant Pharmaceutical International's clindamycin phosphate and benzoyl peroxide 1.2%/3.75% today for the once-daily treatment of both non-inflammatory and inflammatory acne in patients 12 and older.

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

The gel, which has no surfactants, alcohol, or preservatives, was examined in a 12-week trial of 498 patients with moderate to severe acne. The gel reduced non-inflammatory lesions by an average of 52% vs. 28% vehicle, according to the Valeant study. For treatment of inflammatory lesions, the gel reduced the lesions by an average of 60% vs. 31% vehicle.

Less than 1% of patients reported an adverse event in the trial, and no patients discontinued the treatment during the trial, according to the study. However, patients should stop using Onexton gel if they experience severe watery or bloody diarrhea; severe itching, swelling of the face, eyes, lips, tongue, or throat; or difficulty breathing.

"Acne is a pervasive disease that, if left unchecked, can have significant impact for patients," said Joshua Zeichner, MD and director of cosmetic and clinical research in the department of dermatology at Mount Sinai Hospital, in a press release. "We encourage people with acne to visit a dermatologist or other health care professionals for treatment. Onexton Gel is an effective topical medication, appropriate for patients with a wide range of acne and has a favorable tolerability profile."

Acne affects 40 million to 50 million people in the United States, according to Valeant.