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CPRX > SEC Filings for CPRX > Form 8-K on 8-Nov-2012All Recent SEC Filings

Show all filings for CATALYST PHARMACEUTICAL PARTNERS, INC.

Form 8-K for CATALYST PHARMACEUTICAL PARTNERS, INC.


8-Nov-2012

Other Events, Financial Statements and Exhibits


Item 8.01 Other Events

On November 8, 2012, Catalyst Pharmaceutical Partners, Inc. (the "Company") issued a press release announcing the top-line results from its Phase II(b) clinical trial evaluating the use of CPP-109 (vigabatrin) to treat cocaine addiction. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The study results showed that CPP-109 did not meet the primary endpoint - that a significantly larger proportion of CPP-109-treated subjects than placebo-treated subjects were cocaine free during the last two weeks of the treatment period (weeks 8 and 9). The data also showed that the two key secondary endpoints, a significantly larger increase in cocaine-negative urine samples and a significant decrease in the weekly fraction of use of days in medication-treated subjects during weeks 3-9, were also not met. The trial did not show any unexpected "serious" adverse events.

The Company expects the remaining protocol-specified analyses for other secondary and exploratory clinical endpoints and safety data to be completed during the first half of next year, after all the follow-up clinical data have been received to be able to fully unblind the trial data. Once the Company has received and had an opportunity to analyze the full data set from the trial, it intends to meet with its collaborator on the Phase II(b) trial, the National Institute of Drug Abuse, in order to determine the next steps, if any, in the clinical development program for CPP-109 for cocaine addiction.



Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

99.1 Press release issued by the Company on November 8, 2012


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