Castle Creek Pharmaceuticals Gets FDA Fast Track Designation for Diacerein 1% Ointment for EBS

Thursday, August 09, 2018 | FDA Approval/Clearance , Product Launches and Updates


The U.S. Food & Drug Administration (FDA) granted fast track status to Castle Creek Pharmaceuticals, LLC’s diacerein 1%, ointment (CCP-020) for the treatment of epidermolysis bullosa simplex (EBS).

"Fast Track designation is an important milestone in our development program for CCP-020 and reinforces the critical unmet need for patients who are living with the risk of severe blistering and skin erosion associated with EBS," says Amir Tavakkol, PhD, executive vice president and chief development officer at Castle Creek Pharmaceuticals, LLC, in a news release. "With no approved treatment available, patients may be unable to participate in many daily activities and often experience severe pain. Fast Track designation for CCP-020 brings new momentum to our goal to bring an effective treatment to people living with EBS in the U.S. and around the world."

Under the Fast Track designation, Castle Creek Pharmaceuticals, LLC. has the opportunity for priority review and more frequent interactions with the FDA throughout the CCP-020 development program. The FDA previously granted Orphan Drug Designation and Rare Pediatric Disease eligibility to CCP-020 for the treatment of epidermolysis bullosa (EB).

Diacerein is a slow-acting, small molecular weight compound of the class anthraquinone with potent anti-inflammatory properties. Diacerein and its active metabolite rhein have been shown to inhibit the in vitro and in vivo production and activity of IL-1β and other pro-inflammatory cytokines. CCP-020 is a formulation of diacerein, 1% ointment developed for topical application. Diacerein in the formulation is hydrolyzed to rhein in the epidermis and dermis following administration and is believed to block an inflammatory signaling pathway associated with EBS resulting in strengthening epidermal tissue and healing of skin blisters.

In a previously completed Phase 2 clinical trial that included 17 patients with EBS, 60 percent of patients treated with a diacerein cream formulation experienced at least a 40 percent reduction in blistering after four weeks of treatment, compared to 18 percent on vehicle. In this study, adverse events (AE) occurred in 6 patients on diacerein versus 11 patients on vehicle. The most notable AEs were increase in blistering (1), pruritus (1) and skin infection (1). However, none of the listed events were considered treatment related or involved the treatment area.

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