Catalyst Reaches Enrollment Target For Its U.S. Phase II Cocaine Trial

By robin_himself · Jan 10, 2009 · ·
  1. robin_himself
    Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a biopharmaceutical company that acquires, in-licenses, develops and commercializes prescription drugs for the treatment of drug addiction, announced that it has reached its patient enrollment target in its Phase II trial evaluating CPP-109 for the treatment of cocaine addiction. CPP-109 is Catalyst's tablet formulation of vigabatrin being developed as a treatment for cocaine and methamphetamine addiction, as well as other addictions and obsessive-compulsive disorders.

    The randomized, double-blind, placebo-controlled clinical trial is assessing safety and efficacy of CPP-109 over a 12 week treatment period, with an additional 12 weeks of follow-up. The specified total of 180 patients have now been enrolled at 11 leading addiction research facilities across the View attachment 6862
    United States. Catalyst expects to have top-line results from the trial during the second quarter of 2009.

    "Meeting the trial's enrollment target represents an outstanding accomplishment for the addiction field," said Eugene Somoza, M.D., Ph.D., Director, Cincinnati Addiction Research Center, and Coordinating Principal Investigator of Catalyst's clinical trial. "At the present time there is no approved pharmacological treatment for cocaine dependence, a chronic brain disorder associated with a very high level of dysfunction, and immense anguish for the afflicted individuals and their families, as well as a major public health problem to society. This is a double-blind, placebo-controlled trial of a promising medication. An effective medication for treating cocaine addiction has been eagerly awaited for a long time by numerous individuals, families, and treatment providers, and this milestone brings us one step closer to the goal."

    "On behalf of everyone at Catalyst Pharmaceutical Partners, I would like to offer our sincere appreciation to the patients, their families, and all of the outstanding healthcare professionals who are participating in this trial," said Douglas Winship, Vice President of Regulatory Operations. "We look forward with great anticipation to the results of this landmark cocaine dependency trial and the opportunity to improve treatment outcomes of such patients everywhere."

    About the Phase II Cocaine Trial

    The Phase II trial is designed as a randomized, double-blind, placebo- controlled, intent-to-treat, multi-center trial to evaluate the safety and efficacy of CPP-109 as a treatment for cocaine addiction. Under the trial protocol, patients are being treated for a period of 12 weeks, with an additional 12 weeks of follow-up. The primary objective of the trial is to demonstrate that a larger proportion of CPP-109-treated subjects than placebo- treated subjects are cocaine-free during their last two weeks of treatment (weeks 11 and 12). Additionally, Catalyst intends to measure a number of secondary endpoints based on reductions of cocaine use and craving.


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  1. Terrapinzflyer
    Study shows seizure drug curbs cocaine use

    MANHASSET, N.Y., Nov. 11 (UPI) -- U.S. researchers say a placebo-controlled, double-blind study has shown vigabatrin, an anti-convulsant drug, also reduces people's use of cocaine and alcohol.

    Medical researchers led by Stephen Dewey at The Feinstein Institute for Medical Research and Dr. Jonathan Brodie of New York University School of Medicine recruited parolees who were cocaine dependent, each using an average of two grams of cocaine daily for nine years.

    While half the participants in the study received a placebo powder mixed into their juice each day, half got a powder containing vigabatrin. After three months, 14 of the 50 study participants who got vigabatrin each day were able to abstain from cocaine use during the final three weeks of the study, compared with only 4 of the 53 who received the placebo.

    The scientists said use of cocaine was detected by twice-weekly urine tests. Those who got the vigabatrin were also far more likely to report abstinence from alcohol, the researchers reported.

    "In animal models, vigabatrin works to reduce the use of virtually every addictive substance," said Dewey. "If this can do for humans what it did for animals, we may have opened the door for addicts around the world to kick their habit."

    The findings appear in the American Journal of Psychiatry.


    there are a number of threads on vigabatrin here
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