FDA Approves Tretinoin and Benzoyl Peroxide Cream for Acne Vulgaris

The US Food and Drug Administration (FDA) approved fixed-dose combination of tretinoin and benzoyl peroxide, 0.1% and 0.3% (TWYNEO) for the treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.

This approval was granted to Sol-Gel Technologies.

The once-daily cream utilizes patented technology that entraps both tretinoin and benzoyl peroxide within silica-based microcapsules. Therefore, tretinoin is stabilized and prevented from being degraded by benzoyl peroxide.

“TWYNEO combines, for the first time, two of the most commonly used topical agents available for the treatment of acne into a single application,” said Hilary Baldwin, MD, Clinical Associate Professor of Dermatology, of Rutgers Robert Wood Johnson School of Medicin, in a statement.

“Due to stability issues, these products don’t play well together, and we were never able to recommend even consecutive co-application of the two agents. Sol-Gel’s technology has solved this problem.”

Supporting Data

The approval was supported by positive results from 2 phase 3, randomized, double-blind, vehicle-controlled, multi-center studies, which demonstrated efficacy of the cream as well as a favorable safety profile.

In both trials, a higher proportion of patients who received the combination cream had at least 2 grade reductions from baseline and “clear” (0) or “almost clear” (1) on the Investigator’s Global Assessment (IGA) scale at week 12.

Additionally, the cream was associated with statistically significant improvements in inflammatory and non-inflammatory lesion counts.

“The FDA approval of TWYNEO underscores our ability to deliver innovative, proprietary drugs to the market,” said Alon Seri-Levy, MD, Co-Founder and CEO of Sol-Gel.

“Based on the clinical data observed,” he continued, “we believe that TWYNEO has the potential to change the treatment landscape for the tens of millions of patients suffering from acne vulgaris. With market leader, Galderma, handling the product launch of TWYNEO, we are excited that TWYNEO will soon be available to patients in the US.”