DCCR

DCCR is a novel, crystalline patent-protected salt of diazoxide in a controlled release once-per-day tablet.

Diazoxide free base is approved as a three times a day oral suspension (Proglycem®) that has been used safely for decades in tens of thousands of patients.  Diazoxide is first line therapy in a range of orphan indications in neonates, children and adults.  Over the last 40 years, there have been more than 3000 peer reviewed publications covering in-vitro, animal model, and clinical results with diazoxide.

Essentialis is pursuing a 505(b)(2) registration process for DCCR.

Essentialis has filed multiple patent applications covering the product and its uses.  Essentialis’ issued (7,572,789) and allowed patents provide composition of matter protection on DCCR to 2028.  Corresponding patents are currently being prosecuted in all major pharmaceutical markets resulting in the grant of a European patent covering the product. 

Essentialis has assembled an extensive toxicological package on the product which shows a wide margin of safety for therapeutically relevant doses.

The Company has completed 5 clinical trials with DCCR including a Phase 2b study. 

The overall development plan for DCCR was discussed in an End-of-Phase 2/SPA meeting in December 2009 and concurrence was reached on the non-clinical and Phase 1 studies required to support approval.  An SPA covering the first of two pivotal trials has been submitted to the FDA.