Catalyst Pharmaceutical Partners, Inc. Announces FDA Designation of CPP-115 as a Fast Track Development Program
CORAL GABLES, Fla., Dec. 20, 2011 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX - News) today announced that its investigational drug, CPP-115, a novel GABA aminotransferase inhibitor, has been designated as a Fast Track development program by the FDA for the treatment of cocaine dependency.
"We are delighted that CPP-115 has been granted Fast Track status by the FDA for the treatment of cocaine dependency, as they have previously done for CPP-109," said Patrick J. McEnany, Catalyst's President and Chief Executive Officer. "Via the development and commercialization of CPP-109, we hope to offer providers and their patients safe and effective therapies for cocaine dependency and other addictions. Our interactions with the FDA as part of the Fast Track program have helped to expedite CPP-109 into its current Phase II(b) trial for cocaine dependency. CPP-115 will allow us to extend and enhance our cocaine dependency franchise and we look forward to expanding our relationship and interactions with the FDA to address this significant unmet medical need."
CPP-115 is a novel GABA aminotransferase inhibitor and vigabatrin analogue that is more potent than vigabatrin and has reduced side effects from those associated with vigabatrin in preclinical studies. Catalyst is planning to develop CPP-115 for several indications, including drug addiction, epilepsy and other selected CNS diseases, and recently initiated a Phase I(a) safety study in 48 healthy subjects. CPP-115 has also been granted orphan-drug designation by the FDA for the treatment of infantile spasms.
About FDA's Fast Track Drug Development Program
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 with benefits that may help to expedite the approval process. For instance, Catalyst may receive input from the FDA regarding the design of its clinical studies, which may expedite the development and review of its FDA submissions and may provide greater overall certainty in the regulatory process, although there is no assurance that this will happen.
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a development-stage biopharmaceutical company focused on the development and commercialization of prescription drugs targeting diseases of the central nervous system with a focus on the treatment of addiction and epilepsy. Catalyst has two products in development, CPP-109 and CPP-115, and is currently evaluating its lead product and first-in-class GABA aminotransferase inhibitor candidate, CPP-109, for the treatment of cocaine addiction. CPP-109 has been granted "Fast Track" status by the U.S. Food & Drug Administration (FDA) for the treatment of cocaine addiction. Catalyst also expects to evaluate CPP-109 for the treatment of other addictions. Catalyst believes that it controls all current intellectual property for drugs that have a mechanism of action related to the inhibition of GABA aminotransferase. For more information about Catalyst, go to www.catalystpharma.com.
