Helsinn Integrative Care, Helsinn’s business unit focused on evidence-based, non-pharmaceutical cancer supportive care products, announced that Xonrid gel, a topical gel for radiotherapy-induced dermatitis, already classified as a medical device in the EU, has received 510(K) FDA clearance in the US.

This now allows Xonrid gel to be marketed in the US for the management and relief of the burning and itching experienced by patients with radiation dermatitis.

Riccardo Braglia, Helsinn Group vice chairman and CEO, commented, “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. It is a non-sterile topical water-based gel that forms a protective barrier on skin to increase moisture and reduce water loss.

Xonrid gel contains numerous ingredients that are grouped into several common ingredient classes, including emollients; preservatives; skin conditioning agents; viscosity-increasing agents; emulsifying agents; and binders. Each ingredient is a well-recognized component of topical cosmetic products that primarily provide the skin conditioning and emollient features of Xonrid® Gel.

Xonrid Gel is applied three times per day or as needed. The product is packaged in a 75 mL bottle equipped with an airless dispending system and a cap. The product is intended to be used for less than 30 days, and has a 36-month shelf life.

The FDA has granted the following indications for use: Under the supervision of a healthcare professional, Xonrid gel is indicated to manage and relieve the burning and itching experienced with radiation dermatitis. Xonrid gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. Not intended to be used on open wounds.

Ionizing radiation is a widely recognized therapeutic approach in the oncology field, for cancer manifestations of different aetiology and localization. In spite of all the advances in medical technology, radiation therapy still causes severe early and late skin effects: among them, RID occurs in approximately 90% of patients.

Important consequences of Radiation Induced Dermatitis include impairment of the quality of a patient’s life due to local pain, and premature interruption of radiation treatment can occur.

Radiation Induced Dermatitis frequently appears within the first four weeks of treatment, with epidermal regeneration, healing and resolution occurring within three-four weeks following end of treatment. Complete healing can take up to three months.