FDA grants orphan-drug designation to Catalyst's CPP-115 investigational drug

Sep 22 2010

Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced that its investigational drug, CPP-115, a novel GABA aminotransferase inhibitor, has been granted orphan-drug designation for the treatment of infantile spasms (West Syndrome) by the U.S. Food and Drug Administration (FDA).

"Orphan-drug designation for the treatment of infantile spasms is an important milestone in the development of CPP-115," said Patrick McEnany, Catalyst's Chief Executive Officer. "Currently, there are limited choices available for treating this serious pediatric disease, all of which have significant side effects. We hope to offer providers and their patients a more effective and safer therapy than is currently available."

Catalyst is currently conducting a number of non-clinical safety and efficacy studies with CPP-115 to support various indications and expects to file an IND with respect to CPP-115 in the first half of 2011.