Vigabatrin: Phase IIb data

Top-line data from the double-blind, U.S. Phase IIb CPP-01005 trial in 207 cocaine addicts showed that CPP-109 missed the primary endpoint of a greater proportion of cocaine-free patients during the last 2 weeks of treatment vs. placebo. CPP-109 also missed the secondary endpoints of a greater proportion of cocaine-negative urine tests and a greater reduction in the weekly fraction of cocaine-use days during weeks 3-9 vs. placebo. Catalyst said it expects to complete the remaining protocol-specified analyses from the trial in 1H13, after which the company will meet with its collaborator, NIH's National Institutes on Drug Abuse (NIDA), to determine next steps. Catalyst also said it will monitor the results of an investigator-sponsored Phase I/II trial of CPP-109 to treat Tourette's disorder to determine if further development is warranted in the indication.

In 2009, Catalyst said it will continue development of CPP-109 to treat cocaine addiction after a post hoc analysis of the Phase II CPP-01004 trial in 186 cocaine addicts showed that <40% of subjects were medication compliant. The company said the low compliance resulted in the study being inadequately powered, but a compliance-corrected analysis of the data showed a trend toward lower cocaine use in the CPP-109 group vs. placebo. The company had previously reported that the product missed the primary endpoint of a greater proportion of cocaine-free patients during the last 2 weeks of treatment vs. placebo (see BioCentury, June 1, 2009 & Oct. 5, 2009). ...