Specialty pharmaceutical company, Sonoma Pharmaceuticals, Inc. has received a new 510(k) clearance from the US Food and Drug Administration (FDA) for the it’s newest product, Loyon Skin Descaler. Loyon is intended to manage skin scaling experienced with various types of dermatoses.
Loyon Skin Descaler is a unique and patented combination of the dry emollient Cetiol CC and the medical silicone oil dimethicone. The product is easily applied and spreads exceptionally well into the cracks and crevices of the scale due to its low surface tension. US commercialization via Sonoma’s dermatology division IntraDerm Pharmaceuticals’ 30-plus-person direct sales team is slated for summer 2017.
“Loyon Skin Descaler has demonstrated an impressive level of efficacy in the management of multiple dermatoses including psoriasis capitis and seborrheic dermatitis since first being commercialized in Europe in 2014,” said Jeffrey Day, president of IntraDerm Pharmaceuticals. “Nearly a quarter of the US population is afflicted with scaling associated with various skin dermatoses and we believe this product, once launched, will provide this community with a most novel tool for assisting with scale removal in their patient populations.”
It is estimated that 25% of the general population has some degree of scaling associated with skin dermatoses. “Although the diagnosis is often overlooked and undervalued, the treatment of the symptoms is just as integral as slowing the process,” said Neal Bhatia, MD., director of clinical dermatology, Therapeutics Clinical Research. “The presentation may be more aggressive in patients with HIV, neurologic disorders, infants and the elderly. More importantly, options for symptom control are limited and dermatologists are in need of new options.”
Sonoma is a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care.