FDA approves Twyneo cream for acne vulgaris
Twyneo cream, a fixed-dose combination of tretinoin and benzoyl peroxide, has been approved by the FDA for the treatment of acne vulgaris, Sol-Gel Technologies announced in a press release.
The cream, which uses the company’s patented technology to entrap the retinoid tretinoin and benzoyl peroxide in silica-based microcapsules, was approved for adults and children 9 years and older.
“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,” Alon Seri-Levy, PhD, co-founder and CEO of Sol-Gel, said in the release.
The approval was based on data from two phase 3 clinical trials in which Twyneo showed efficacy and tolerability in patients with facial acne vulgaris.
The company is partnering with Galderma for commercialization in the Unites States. As part of the partnership, Sol-Gel will receive a regulatory milestone payment for this approval and will retain the option to regain U.S. commercialization rights 5 years after initial commercialization.
“Galderma was founded 40 years ago around a commitment to serve the dermatological needs of health care professionals and their patients,” Baldo Scassellati Sforzolini, global head of research and development at Galderma, said in the release. “Our heritage in acne dates back to our founding, and we are excited to partner with Sol-Gel to bring yet another acne innovation to market for a condition that impacts up to 50 million Americans annually.”