The Food and Drug Administration (FDA) has granted Orphan Drug Designation to PCS499 (Processa Pharmaceuticals) for the treatment of necrobiosis lipoidica, a rare, necrotizing skin condition that affects both men and women and is frequently seen in patients with diabetes, particularly type 1 diabetes.

Currently, there is no FDA approved treatment for necrobiosis lipoidica. In a press release Dr. David Young, CEO of Processa said “We plan to begin our clinical studies in 2018 and to accelerate the development of PCS499 in order to provide clinical benefit to [necrobiosis lipoidica] patients as soon as possible.” 

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The Company will also be investigating PCS499 as a potential treatment for adverse effects related to radiation therapy, such as radiation-induced salivary dysfunction, soft tissue and muscular fibrosis, mucosal atrophy, vascular and neural damage, ulceration and necrosis.

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