The FDA Just Approved a New Acne Cream and It’s Dermatologist-Approved


On July 28, Twyneo Cream, a first-of-its-kind combination of tretinoin and benzoyl peroxide (BPO), was approved by the FDA for the treatment of acne, and a dermatologist says it works dramatically better than the two main ingredients alone.

The cream, which was developed by Sol-Gel Technologies, was approved for adults and children nine years and older. This approval was based on data from two different phase-three clinical trials in which the drug showed acne-clearing efficacy on patients within this age range.

“Based on the clinical data observed, we believe that Twyneo has the potential to change the treatment landscape for the tens of millions of patients suffering from acne vulgaris,” says co-founder and CEO of Sol-Gel Alon Seri-Levy, PhD according to a release. Currently partnering with pharmaceutical company Galderma for commercialization in the Unites States, Sol-Gel will have the option to regain commercialization rights five years after the commencement of this partnership.

According to Spokane, WA dermatologist Wm. Philip Werschler, MD, what makes Twyneo different is “the micro-encapsulation of the two base products in silica-derived protective ‘shells.’ This accomplishes two things: First, it allows the tretinoin and BPO to be packaged together, which is a unique scenario as BPO is a reactive product that can degrade other ingredients. Second, the slow release of both products helps to minimize irritation upon use.” Dr. Werschler, who was a clinical investigator for the Twyneo FDA trials, also explains why these ingredients work well together if formulated correctly: “BPO and tretinoin act on different pathways of the genesis of acne. Thus, there is a synergy when used together that exceeds their individual use.”

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