Catalyst Pharmaceutical Partners has received fast-track designation from the US food and Drug Administration (FDA) for CPP-115, a novel drug to treat cocaine dependency.
CPP-115, a GABA aminotransferase inhibitor, has shown the potential to be more potent than vigabatrin, the standard drug to treat cocaine abuse, and has shown reduced side effects from those associated with vigabatrin in pre-clinical studies.
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Catalyst’s President and Chief Executive Officer Patrick McEnany said, “Via the development and commercialisation of CPP-109, we hope to offer providers and their patients safe and effective therapies for cocaine dependency and other addictions.”
Catalyst is planning to develop CPP-115 for several indications, including drug addiction, epilepsy and other selected CNS diseases, and recently initiated a Phase Ia safety study in 48 healthy subjects.
CPP-115 has also been granted orphan-drug designation by the FDA for the treatment of infantile spasms.
The regulator’s fast-track drug development programme allows for the expedited review of drugs and biologics intended to treat serious or life-threatening conditions.
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