Helsinn Integrative Care, a Helsinn's business unit, which focuses on evidence-based, non-pharmaceutical cancer supportive care products, has received 510(K) clearance from the US Food and Drug Administration (FDA) for its Xonrid Gel, a topical gel for radiotherapy-induced dermatitis, already classified as a medical device in Europe.
With the 510(K) clearance, Xonrid Gel can be marketed across the US and can be used for the management and relief of the burning and itching experienced by patients with radiation dermatitis.
Helsinn Group vice chairman and CEO Riccardo Braglia said: “Helsinn Integrative Care aims to respond to the growing demand from patients for non-pharmaceutical approaches for the management of cancer symptoms solutions backed by robust, evidence-based data.
‘We hope to be able to support both patients and healthcare providers to make informed choices about cancer management.
“Clearance from the FDA for Xonrid Gel will allow wider access to cancer patients experiencing dermatitis as a painful side effect of radiation, and is a validation of our approach to this new and under-served market.”
Xonrid Gel is a multi-component prescription medical device product, which is a non-sterile topical water-based gel that forms a protective barrier on skin to increase moisture and reduce water loss.
The Gel contains various ingredients and are grouped together into several common ingredient classes, including emollients, preservatives, skin conditioning agents, as well as viscosity-increasing agents, emulsifying agents; and binders.