FDA grants orphan drug status to Catalyst Pharma CPP-115

Catalyst Pharma 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.

Catalyst Pharma CEO Patrick McEnany said that Orphan-drug designation for the treatment of infantile spasms is an important milestone in the development of CPP-115.

“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,” McEnany said.