A 517-patient Phase 2 trial of Epiduo(TM) Gel published last year in the Journal of the American Academy of Dermatology demonstrates that Epiduo(TM) Gel reduced the median number of total acne lesions by more than 50 percent at the end of the 12-week study, which was significantly better than monotherapy with either adapalene (35.4 percent median reduction in total lesion count) or benzoyl peroxide (35.6 percent median reduction in total lesion count) alone. In addition, the Epiduo(TM) Gel combination therapy worked quickly, with some patients showing improvements after one week of therapy.
A long-term safety and efficacy assessment of Epiduo(TM) Gel published last year in the Journal of Drugs in Dermatology showed that discontinuation of the medication due to adverse events was low - occurring in only 2 percent of all patients. Additionally, none of the 452 patients withdrew from the study as a result of a lack of efficacy.
These studies also showed that Epiduo(TM) Gel is well-tolerated, and rates of side effects were low in all Epiduo(TM) Gel groups. Clinical trials have demonstrated that Epiduo(TM) Gel is well-tolerated from week 1 to week 52, with the majority of patients experiencing low levels of skin irritation associated with the drug.
"The recent FDA approval and upcoming availability of Epiduo(TM) Gel are examples of Galderma's strong research and development capabilities and our ongoing commitment to providing innovative treatment options to patients," said Albert Draaijer, President, Americas, Galderma Laboratories, L.P. "As an industry leader in the dermatology space, our g
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