Catalyst Pharmaceutical Partners Says FDA Has Accepted IND Application for CPP-109 to Treat Cocaine Addiction

The following news release was issued by Catalyst Pharmaceutical Partners (CPP), the company that owns the license to GVG for the treatment of addiction. CPP Contact: Mr. Patrick J. McEnany, Chief Executive Officer, Catalyst Pharmaceutical Partners, 305-529-2522,

CORAL GABLES, Fla., Jan. 3 — Catalyst Pharmaceutical Partners today announced that the U.S. Food and Drug Administration has allowed its Investigational New Drug Application ("IND") to evaluate Catalyst_s lead compound, CPP-109, as a potential pharmaceutical therapy for treating cocaine addiction. Allowance of the IND permits Catalyst to initiate a Phase 1 clinical trial, which is designed to assess the safety of the interaction of CPP-109 and cocaine in a clinical setting. Catalyst expects to commence this trial in the first quarter of 2005.

Photo of Stephen Dewey

Comments from Brookhaven_s Stephen Dewey: "I_m extremely excited about today_s news," said Brookhaven neuroanatomist Stephen Dewey, who began investigating the use of GVG for the treatment of addiction at Brookhaven Lab in 1986. "From the beginning, the U.S. Department of Energy_s (DOE_s) Office of Science has consistently supported our work. Only after we established an extensive database were we successful in obtaining and maintaining funding from the National Institutes of Health. So the commitment of DOE has been vital to getting us this far. This is a credit to DOE and to those in the Office of Biological and Environmental Research within the Office of Science. Its also a credit to everyone with whom I_ve collaborated over the years."

The medical-imaging technologies and radiotracers used by Dr. Dewey in this work are a direct outgrowth of the Department of Energy_s long-standing investment in basic physics research, particularly the development of particle accelerators to answer questions about the fundamental nature of matter and energy.

See a short video of Dr. Dewey discussing approaches to addiction treatment. (Requires RealPlayer software.)

About Catalyst Pharmaceutical Partners

Catalyst Pharmaceutical Partners of Coral Gables, Florida, 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. In October 2002, Catalyst received an exclusive worldwide license from Brookhaven Science Associates, operator of Brookhaven National Laboratory, for the use of the drug gamma vinyl-GABA, also known as vigabatrin or GVG, for its application in treating drug addiction.

About CPP-109

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 neurotransmitter. 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 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, including cocaine.

About Brookhaven National Laboratory

Brookhaven National Laboratory 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, (

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