Topical Treatment for Epidermolysis Bullosa Gets FDA's Rare Pediatric Designation
The Food and Drug Administration (FDA) has granted rare pediatric disease designation to diacerein 1% ointment (CCP-020; Castle Creek Pharmaceuticals) for the treatment of epidermolysis bullosa (EB), a rare condition characterized by extremely fragile skin that results in blistering, skin erosion and peeling in response to minor injury.
Diacerein is a anthraquinone with potent anti-inflammatory properties. CCP-020 is a formulation of diacerein developed specially for topical application; the product is currently being evaluated in a clinical trial (DELIVERS) in patients with epidermolysis bullosa simplex, a subtype of EB. A previous Phase 2 trial of 17 patients with EBS showed that 60% of patients treated with diacerein cream formulation experienced at least a 40% reduction in blistering after 4 weeks vs 18% using vehicle.
"We look forward to advancing the clinical development of CCP-020 in our ongoing DELIVERS study and fulfilling our mission to improve the health and quality of life for people living with EBS in the years ahead," said Michael Derby, CEO of Castle Creek Pharmaceuticals.
For more information visit Deliversebs.com.