Foamix to file acne treatment after successful late-stage trials
Israel's Foamix has said it is planning a US filing of its minocycline-based topical acne treatment after positive late stage trial results.
The third phase 3 trial of FMX101, a topical minocycline foam designed to treat moderate to severe acne, showed a significant reduction in the number of inflammatory lesions.
The treatment was deemed safe and well tolerated, with upper respiratory tract viral infection the most commonly reported adverse side effect.
David Domzalski, CEO of Foamix, said, “We are extremely pleased with the topline results of this confirmatory phase 3 trial. These study results should support a finding that FMX101 appears to be safe and effective in the treatment of moderate-to-severe acne.
“This is the most significant milestone to date for Foamix and brings us closer to helping patients who struggle with the physical and psycho-social effects of acne. If approved, we believe FMX101 would be the first topical minocycline product available for patients in the United States.”
Shares in Foamix surged in pre-market trading on the Nasdaq after the company said it plans to file a dossier with the FDA seeking approval.
The FDA has 60 days within which to decide whether it intends to file it or reject it. If the application is deemed as incomplete, it can reject or request for more information within the first 60 days.
A standard FDA review takes up to 10 months, paving the way for a launch late next year, or in early 2020 if the regulator deems the treatment to be safe and effective.
Acne affects approximately 40-50 million people in the US alone. Around 10 million of these have moderate-to-severe acne that significantly impacts their self-esteem and quality of life.
Recently, the US FDA approved the Ortho Dermatologics treatment, Altreno (tretinoin 0.05%), for acne sufferers aged nine and above.
Altreno is the first formulation of tretinoin in a lotion, and has been shown to be effective and generally well-tolerated. It is expected to be available during the fourth quarter of this year.
The lotion is said to be moisturising, in contrast to other forms of retinoids, which can cause dryness, pain and peeling.
Two phase 3 studies of 1,640 patients in total were carried out. The results showed that Altreno lotion resulted in statistically significant reductions in inflammatory and non-inflammatory lesions compared to the vehicle ingredient.
Bill Humphries, president, Ortho Dermatologics, said, “Altreno lotion spreads easily and is quickly absorbed into the skin allowing acne patients to easily incorporate this once-daily treatment into their skin care regimen.”