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CORAL GABLES, Fla., Sept. 26, 2012 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) announced today that it has been advised by the Department of Veterans Affairs Cooperative Studies Program (VACSP) that the availability of top-line results from Catalyst's CPP-109 (vigabatrin) Phase II(b) trial for cocaine addiction will be delayed. VACSP now expects to provide the top-line results to the Company during the first half of November 2012. VACSP is the Company's collaborator responsible for the management and statistical analyses of the data being collected from the trial.
Patrick J. McEnany, Catalyst's Chairman and Chief Executive Officer, stated: "Previously, VACSP had advised us that they would be able to provide top-line results from our trial around the end of September 2012. However, they have now indicated that it is taking longer than they had originally anticipated to obtain, verify and lock the drug use data from the trial, therefore delaying the timing of the delivery of the top-line results to us. We still expect to report these results significantly earlier than we had originally anticipated."
About the CPP-109 Phase II(b) Clinical Trial
The 24-week CPP-109 Phase II(b) clinical trial is randomized, double-blind and placebo-controlled in 207 patients recruited at 13 sites in the United States. It is designed to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 who abstain from cocaine use in the last two weeks of the trial's treatment phase (weeks 8 and 9) will be higher than patients treated with placebo. Other outcomes include: i) reduction in cocaine use days; ii) increase in clean urines collected; and iii) improvements in other measures of subject well-being and cocaine craving.
About CPP-109 and Fast Track Status
CPP-109 is a GABA analog that is Catalyst's designation for vigabatrin. Catalyst licensed CPP-109 from Brookhaven National Laboratory for the treatment of cocaine and other addictions, and has been granted "Fast Track" status by the U.S. Food and Drug Administration (FDA) for cocaine addiction. Under the Federal Food, Drug, and Cosmetic Act, the FDA is directed to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. Fast Track designation emphasizes communication between Catalyst and the FDA, and provides Catalyst benefits that may help to expedite the approval process. For example, Fast Track designation affords Catalyst the potential to submit a New Drug Application (NDA) for CPP-109 on a rolling or modular basis, allowing the FDA to review sections of the NDA in advance of receiving a full submission. The designation also means that Catalyst may have increased communications with the FDA regarding the design of its clinical studies, which may expedite the development and review of Catalyst's application for the approval of CPP-109 for cocaine addiction and may provide greater certainty overall in the regulatory pathway.