The US Food and Drug Administration (FDA) yesterday approved a topical gel combination of adapalene 0.3% and benzoyl peroxide 2.5% (Epiduo Forte, Galderma) for the treatment of acne vulgaris, the company has announced.
The approval was based on a phase 3 randomized double-blind study involving 217 patients, all aged 12 years and older, with an average patient age of 20 years. In the study, Epiduo Forte gel was superior to vehicle control gel in the overall study population of patients with moderate to severe acne at week 12 for the Investigator's Global Assessment Success Rate and for changes in inflammatory and noninflammatory lesion count, the company notes in a news release announcing the approval.
In addition, half of the patients had severe acne at baseline, and more than half of this group (50.5%) saw marked improvement during the study, with results seen as early as 1 week, with continued improvement through week 12, according to the company.
"Acne is a challenging condition to manage. It can vary greatly from patient to patient, can have a significant physical and psychosocial impact on sufferers, and patients can find treatment adherence difficult to maintain," Jonathan Weiss, MD, a board-certified dermatologist at Gwinnett Dermatology, PC, and lead investigator on the study, said in the news release.
"For many patients, rapid results are especially important, and some acne treatments take time to show effect. We were very excited to see in the clinical trial that people using Epiduo Forte gel saw results as early as 1 week, with efficacy continually improving through week 12," Dr Weiss added.
Erythema, scaling, dryness, stinging/burning, and irritant and allergic contact dermatitis may occur with Epiduo Forte, requiring discontinuation in some cases.
Patients using Epiduo Forte gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided, the company said.
Epiduo Forte gel will be available by prescription beginning in September.
The formulation of adapalene 0.1% and benzoyl peroxide 2.5% (Epiduo) was approved by the FDA in 2009 for use in patients 12 and older.
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Cite this: FDA OKs Epiduo Forte Gel for Acne - Medscape - Jul 17, 2015.