Galderma earns FDA approval for new antibiotic-free treatment for acne

Epiduo Forte Gel, a new antibiotic-free treatment for acne from Galderma Laboratories, received approval from the U.S. Food and Drug Administration (FDA) on July 17.

Epiduo Forte Gel is designed for those with moderate to severe acne, and is the first
combination of the strengths of the retinoid, adapalene and benzoyl peroxide.

"As the industry leader in dermatology, Galderma recognizes the need for innovative acne medications across a spectrum of acne severities,” said Todd Zavodnick, president and general manager of Galderma. “The FDA approval of Epiduo Forte Gel has helped us expand on our robust acne franchise to deliver a safe, effective and antibiotic-free treatment to patients in need, and underscores Galderma’s continued commitment to skin health and antibiotic stewardship.”

The treatment earned its approval after a 12-week controlled study in which it met its efficacy goals compared to vehicle gel in 217 subjects. Epiduo Forte Gel was shown as superior to the vehicle gel by week 12 for the investigator’s global assessment success rate and for changes in the inflammatory and non-inflammatory lesion count. It was also successful in treating "severe" acne, with more than half of the participants reporting a marked improvement, the company said.

Epiduo Forte Gel will be available by prescription in early September, Galderma  said.
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