Foamix Pharmaceuticals is seeking the US Food and Drug Administration (FDA) approval for FMX103 to treat moderate-to-severe papulopustular rosacea in patients aged 18 years and above.
The company has submitted a new drug application (NDA) to the FDA in this regard.
Rosacea is a common skin condition that causes redness and visible blood vessels in the face. It may also produce small, red, pus-filled bumps.
Foamix Pharmaceuticals CEO David Domzalski said: “It can be challenging for patients with papulopustular rosacea to find therapies that provide meaningful symptom relief and are also well-tolerated when applied to their skin.
“Building on the impressive Phase III FMX103 topline results announced in November last year, we are excited to have reached this NDA submission milestone earlier than previously anticipated.”
The company’s latest NDA submission supports previous results obtained from two Phase III clinical trials, FX2016-11 and FX2016-12, in which FMX103 achieved both co-primary endpoints.
In both trials, FMX103 demonstrated statistically significant improvements in inflammatory lesion count and investigator global assessment (IGA) treatment success.
The submission also includes information on chemistry manufacturing and controls, as well as data from non-clinical toxicology studies.
Foamix Pharmaceuticals chief scientific officer Iain Stuart said: “Our goal with developing FMX103 is to provide patients with an efficacious and well-tolerated treatment in a convenient topical foam formulation.
“This submission for FMX103, which is the second NDA submitted by Foamix within the past eight months, underlines both the potential of our late-stage portfolio in dermatology as well as the strong execution capabilities of our R&D and regulatory teams.”