CORAL GABLES, Fla., Dec. 8 /PRNewswire/ -- Catalyst Pharmaceutical Partners today announced the submission of an investigational new drug application ("IND") to the U.S. Food & Drug Administration ("FDA") to evaluate Catalyst's lead compound, CPP-109, as a potential pharmaceutical therapy for treating cocaine addiction. As a result of the IND submission, Catalyst expects to commence a Phase I human clinical trial to assess the safety of the interaction of CPP-109 and cocaine in a clinical setting.
CPP-109 or "vigabatrin/GVG to treat addiction" works by inhibiting an enzyme that normally breaks down gamma amino butyric acid (GABA), a dopamine- modulating enzyme. The resulting excess GABA breaks down the excess dopamine. All addictive drugs elevate dopamine levels in the parts of the brain associated with reward and reinforcement. It is thought that this reinforcing effect is the primary biochemical explanation for addiction. CPP-109 indirectly depletes dopamine.
Catalyst's interest in CPP-109 is based on the results of two small-scale human trials conducted in Mexico using CPP-109 and a large body of preclinical research using the drug as a potential treatment for addiction conducted by Dr. Stephen Dewey of Brookhaven National Laboratory (BNL) and Dr. Jonathan Brodie, a psychiatrist at the New York University School of Medicine. Results from these trials show that CPP-109 holds promise as a treatment for addiction to a variety of abused drugs.
"The filing of the IND for CPP-109 is the first step in our clinical development plan for the U.S. market. CPP-109 represents a promising pharmacological therapy for treating cocaine addiction and other substance abuse, a major healthcare and social issue in the U.S.," said Patrick J. McEnany, Catalyst CEO.
In October 2002, Catalyst received an exclusive worldwide license from Brookhaven Science Associates, operator of Brookhaven National Laboratory, for the use of the drug GVG for its application in treating drug addiction.
Catalyst Pharmaceutical Partners of Coral Gables, Florida ( http://www.catalystpharma.com/ ) is a privately held specialty pharmaceutical company, focused on the acquisition or in-licensing, development and commercialization of novel prescription drugs for the treatment of drug addiction.
Brookhaven National Laboratory (Brookhaven) is one of ten national laboratories overseen and primarily funded by the Office of Science of the U.S. Department of Energy (DOE). Brookhaven conducts research in the physical, biomedical, and environmental sciences, as well as in energy technologies and national security. Visit Brookhaven Lab's electronic newsroom for links, news archives, graphics, and more regarding GVG ( http://www.bnl.gov/PET/GVG ).
Catalyst Pharmaceutical Partners