Ortho Dermatologic’s New Altreno Acne Cure Approved by FDA
The Food and Drug Administration (FDA) of the United States recently approved the new drug application for Altreno (tretinoin 0.05%). The company behind this new lotion treatment for acne vulgaris is Ortho Dermatologics.
The FDA approved the treatment in the beginning of October for use in patients aged nine years and older. According to a news release, this formula is the first of its kind in the form of a lotion. The market expects to see this product on the shelves by the last quarter of the year.
Physicians note that retinoids tend to often result in irritation of the skin. However, they mentioned that this new lotion can now help provide an attractive option for many people around the country who suffer from acne.
Ortho Dermatologics and Their New Treatment Altreno
Joshua Zeichner, M.D., is the director of Cosmetic and Clinical Research in Dermatology at Mount Sinai Hospital in NY City. He explained that since there is an expected efficacy from retinoids, he is confident the new treatment will help many of his patients. Especially with the proven tolerability profile
According to Ortho Dermatologics, the lotion is readily applicable, and the skin absorbs it quickly. Altreno underwent two vehicle-controlled phase 3 studies that were randomized and double-blind. The studies consisted of 1,640 patients, and the lotion demonstrated significant reductions in both noninflammatory and inflammatory lesions compared to vehicle. During week 12, 16.5% and 19.8% of patients in both trials showed the success of treatment of 2-grade improvement or more in global severity by Evaluator Global Severity Scores compared to 6.9% and 12.5% with vehicle. Less than 4% of patients reported adverse side effects including dry skin, irritation, swelling, peeling, or pain.
Ortho Dermatologics President Bill Humphries said that the FDA approval of Altreno builds on their strong acne portfolio. It helps provide physicians as well as patients with a trusted retinoid in lotion form. Humphries said they formulated Altreno to enhance the experience and include moisturizing attributes of hyaluronic acid, collagen, and glycerin.