FDA approved Galderma Laboratories’ antibiotic-free adapalene and benzoyl peroxide 0.3%/2.5% gel (Epiduo Forte Gel) for the once-daily treatment of acne vulgaris.
“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,” said clinical investigator Jonathan Weiss, MD, in a press 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.”
The most commonly reported adverse events experienced by trial participants treated with Epiduo Forte Gel were skin irritation, eczema, atopic dermatitis, and skin burning sensation. Most of the side effects associated with the drug’s use were mild and moderate in severity, a finding that Galderma considers particularly relevant to acne patients with sensitive skin.
Galderma plans to launch Epiduo Forte Gel in early September 2015, according to a manufacturer press release.
“This post offers a very informative snapshot of how the FDA’s approval of new prescription options has progressed over time. It’s fascinating to see how innovations like adapalene/benzoyl peroxide gels expanded the toolkit for managing acne, giving dermatologists and patients more reliable acne treatment choices backed by clinical data. While newer therapies have continued to emerge since this article was published, this piece still serves as a helpful reminder of how regulatory approvals can meaningfully impact the options available to people dealing with persistent breakouts from prescription gels to the cutting-edge combination products that came later.
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