Anxiety/Depression
Product Candidate Description
This is a naturally-occurring, small molecule that has been shown to be both safe and efficacious in preliminary evaluations in children and adults as well as in dogs with separation anxiety and horses that are high strung and difficult to train.
Laboratory Status
The therapeutic agent has been isolated and thoroughly characterized. In conjunction with collaborators at the University of North Carolina at Chapel Hill, it has been clearly demonstrated that this product candidate produces statistically significant results in validated lab animal models for both anxiety and depression, and it acts in a fashion different from that of any antidepressant currently on the market. This suggests a “first in class” designation with the FDA.
Clinical Status
Physicians and veterinarians have used this agent to treat anxiety or depression in more than 50 human patients and approximately half that number of animals. Results have been consistently positive in the absence of adverse events.
Path Forward
Mechanism-of-action studies should be continued to completion and controlled human trials initiated.