A fixed-dose combination for the treatment of Cocaine Use Disorder (CUD), with a strategic focus on patients with co-morbid Post-Traumatic Stress Disorder (PTSD). For nearly four decades, the medical community has searched for an effective pharmacotherapy for CUD without success, leaving a significant and desperate unmet medical need. Our program represents the first scientifically robust, late-stage clinical effort poised to break this impasse.
This asset is a repurposed combination of two well-characterized drugs, enabling an efficient regulatory pathway and leveraging a designation as a Breakthrough Therapy. Strong human proof-of-concept has already been established in a placebo-controlled clinical study, and we are currently initiating a Phase 2 program.