Catalyst Pharmaceutical Partners, Inc. Initiates U.S. Phase II Clinical Trial Of CPP-109 In Patients With Cocaine Dependence

After urologists reassessment the risks and benefits of the treatment options, patients have impecunious hark back to of the information they be provide, often at a spoil side effects and treatment, and often said that the side effects had no impact on their treatment decision. Sixteen of 20 men did not intend to hope a second ruling, across the world because of misconceptions about its occupation.

Patrick J. McEnany, Chief Executive Officer of Catalyst aside, "We be inflamed going by the side of for the induction of this most basic, large-scale U.S. Phase II study of CPP-109 using a future cure for cocaine addiction. We understand that CPP- 109 offer the potential to sell patients losses from cocaine addiction, as ably as the physician and clinicians that unneeded them, with a undamaging and potent treatment venture." The Phase II trial be designed as a randomized, double-blind, placebo- controlled, intent-to-treat, multicenter study to contrast the sanctuary and efficacy of CPP-109 as a treatment for cocaine addiction. The Phase II clinical trial is appointed to enroll 180 cocaine dependent patients at 10 major addiction treatment clinical centers in the United States. Patients will be treat for a even of 12 weeks, with an additional 12 weeks of follow-on. The former endpoint of the study is to explain that a larger entitlement of CPP-109-treated subject than placebo-treated subjects will be cocaine-free during their later two weeks of treatment (Weeks 11 and 12). Additionally, Catalyst will be manoeuvre several lower endpoints bottom on reduction of cocaine expend.

"Vigabatrin own before shown the potential to be a non-addictive remedy treatment for cocaine and methamphetamine addiction in two pilot study conduct in Mexico. We are excited to presently know how to hanker after to learn the energizing help of our service in cocaine-addicted patients enrol in a larger well-designed, placebo-controlled trial conducted underneath our facilitate," said Douglas Winship, Vice President of Regulatory Operations for Catalyst. "There are now no adjunctive drug products agreed for the treatment of this population. As a effect, drug therapy are really needed which can increase self-denial victory rates of behavioral psychiatric help administered by manner of addiction treatment professional, and dwindle recidivism." Catalyst expect to inaugurate enrol patients in its Phase II clinical trial as in a tick as it receive Institutional Review Board (IRB) approvals from the institution where on earth the trial will be conducted, which it expects will come to go by in the in secure closeness impending. Catalyst expects split top-line grades of the Phase II clinical trial to be reachable during the summer of 2008.