A first-in-class, oral prolonged-release (PR) ketamine tablet for the treatment of refractory chronic pain, beginning with the orphan indication of Complex Regional Pain Syndrome (CRPS). Our therapeutic strategy is built on a novel approach that leverages a proprietary formulation to maximize the generation of therapeutic metabolites while minimizing the psychoactive and cardiovascular side effects that have long hindered ketamine’s potential as a chronic oral therapy. The program is supported by a robust Phase 1 clinical data package demonstrating an excellent safety profile that validates our mechanism, and is poised to enter a Phase 2 clinical trial CRPS designed to demonstrate clinical proof-of-concept.