Foamix files NDA seeking FMX103 FDA approval for rosacea

Filed under: Pharma Regulatory News | Tags: , , , , , , , ,

Israeli pharma company Foamix Pharmaceuticals has filed a new drug application (NDA) for FMX103 to the US Food and Drug Administration (FDA) seeking FMX103 FDA approval for moderate-to-severe papulopustular rosacea in patients, aged 18 years and over.

Considered to be a common skin condition, rosacea results in redness and visible blood vessels in the face. It may also result in small, red, pus-filled bumps.

David Domzalski – CEO of Foamix Pharmaceuticals, commenting on the NDA filing seeking FMX103 FDA approval, 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 3 FMX103 topline results announced in November last year, we are excited to have reached this NDA submission milestone earlier than previously anticipated.”

FMX103 FDA approval for rosacea

Foamix files NDA seeking FMX103 FDA approval for rosacea. Photo courtesy of Stuart Miles/

The submission of the NDA is backed by the previously communicated results from a couple of phase 3 clinical trials – FX2016-11 and FX2016-12. In the two late-stage clinical trials, FMX103 achieved the co-primary endpoints by delivering statistically significant improvements in inflammatory lesion count and Investigator Global Assessment (IGA) treatment success.

In the FX2016-11 and FX2016-12 trials, and in the long-term safety extension study FX2016-13, FMX103’s safety profile was observed to be generally favorable and consistent across the clinical development program. The NDA submission also contains details on chemistry manufacturing and controls and data from non-clinical toxicology studies.

Commenting on the NDA submission seeking FMX103 FDA approval, Iain A. Stuart – Chief Scientific Officer of Foamix Pharmaceuticals 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 8 months, underscores both the potential of our late stage portfolio in dermatology as well as the strong execution capabilities of our R&D and regulatory teams.”

Related posts

Leave a Reply

Your email address will not be published. Required fields are marked *