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The FDA has approved Ortho Dermatologic’s new drug application for Altreno (tretinoin 0.05 percent) lotion for the treatment of acne vulgaris.
The U.S. Food and Drug Administration has approved Ortho Dermatologic’s new drug application for Altreno (tretinoin 0.05 percent) lotion for the treatment of acne vulgaris.
Approved for use in patients ages nine and older, the formulation is the first of its kind in a lotion, according to a company news release. It is expected to be on the market by the fourth quarter of 2018.
Noting that retinoids often result in skin irritation, physicians stated that the new lotion provides an attractive option for many patients suffering from acne.
“With the efficacy expected from a retinoid plus a proven tolerability profile, Altreno will be an ideal choice for many of my patients,” Joshua Zeichner, M.D., director of Cosmetic and Clinical Research in Dermatology at Mount Sinai Hospital, New York City, commented in the news release.
Ortho Dermatologics states the lotion spreads easily and is quickly absorbed by the skin. In two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies of 1,640 patients, Altreno demonstrated statistically significant reductions in inflammatory and noninflammatory lesions compared to vehicle. At week 12, 16.5 percent and 19.8 percent of patients in trials 1 and 2, respectively, demonstrated treatment success of at least a 2- grade improvement in global severity by Evaluator Global Severity Scores, compared to 6.9 percent and 12.5 percent with vehicle. Skin dryness, swelling, irritation, peeling and pain was reported by fewer than 4 percent of patients.
“FDA approval of Altreno builds upon our strong acne portfolio, providing physicians and patients a trusted retinoid in a lotion formulated to enhance the user’s experience with the inclusion of moisturizing attributes of hyaluronic acid, glyercin and collagen,” stated Ortho Dermatologics President Bill Humphries.