EU approves Epiduo 0.3% / 2.5% gel (adapalene/ benzoyl peroxide) for acne- Galderma

Galderma announced that it has received a Positive Opinion from 16 concerned European regulatory agencies for the market approval of Epiduo 0.3% / 2.5% gel (adapalene/ benzoyl peroxide), for the cutaneous treatment of acne vulgaris, when comedones, numerous papules and pustules are present. Epiduo 0.3% / 2.5% gel contains a fixed-dose combination of Adapalene (3 mg/g) and Benzoyl Peroxide (BPO, 25 mg/g) as previously approved Epiduo 0.1% / 2.5% gel, but with a higher concentration of Adapalene, which provided increased clinical benefit in the subjects with numerous papulopustules treated with Epiduo 0.3% / 2.5% gel compared with the lower strength.

With a once-daily application of Epiduo 0.3% / 2.5% gel in the evening to the entire affected areas of the face and the trunk, early signs of clinical improvement usually appear after 1 to 4 weeks of treatment. Galderma expects Epiduo 0.3% / 2.5% gel to be available in pharmacies in Europe as of 2017. The Marketing Authorisation application of Epiduo 0.3% / 2.5% gel was based on a 12-week, multicenter, randomised, double-blind, controlled clinical study, which involved 503 patients with an acne severity assessed as "moderate" (IGA3) or "severe" (IGA4) at baseline (50% in each subgroup). Epiduo 0.3% / 2.5% gel is the only approved topical product studied with at least half of patients being severe (IGA4). Epiduo 0.1% / 2.5% gel was included in the trial as a reference therapy. In the analysis in subjects graded as "severe", Epiduo 0.3% / 2.5% gel achieved a greater efficacy over vehicle with a treatment difference of 20.1%, whereas the reference therapy did not.