Catalyst Pharmaceutical
Partners, Inc. CPRX today announced top-line results from its U.S.
Phase II(b) clinical trial evaluating the use of CPP-109 (vigabatrin) to treat
cocaine addiction. The data from the trial 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 urines and a significant decrease in the weekly
fraction of use days in medication-treated subjects during weeks 3-9, also
were not met. The clinical trial did not reveal any unexpected "serious"
adverse events.
Catalyst 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.
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