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.
The active agent of BTL-ng 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.
The UNC at Chapel Hill researchers have published on their work and have also presented earlier results at the World Federation of Societies of Biological Psychiatry Conference, Sydney, Australia. The investigators have also conducted studies indicating the potential of BTL-ng to address addictions and cravings.
Physicians and veterinarians have used this agent to treat cravings, depression or anxiety. Results have been consistently positive in the absence of adverse events.
Mechanism-of-action studies will be continued to completion and controlled human trials initiated. Peter Monti, Ph.D., Donald G. Miller Distinguished Professor of Alcohol and Addiction Studies at Brown University Medical School, will be principal investigator for two FDA-authorized clinical trials focusing on ethanol and nicotine cravings, with both trials having deperssion as secondary endpoints.