Catalyst Pharm updates EC stance on CPP-115

Catalyst Pharmaceutical Partners announced that the European Commission, EC, has granted orphan medicinal product designation for the company's investigational drug, CPP-115, a novel GABA aminotransferase inhibitor, for the treatment of West Syndrome (infantile spasms). The EC designation is based on the recommendation by the European Medicines Agency (EMA) Committee on Orphan Medicinal Products (COMP) after their review of all relevant preclinical data for CPP-115, which showed that it may have a longer duration of action, improved benefits and fewer retinal side effects than the existing first-line treatment. "We have hit another major milestone in our efforts to advance this clinically important treatment for patients around the world," said Patrick J. McEnany, Chief Executive Officer of Catalyst. "Obtaining an orphan designation for CPP-115 in the European Union (EU) is an important step that builds upon our recent progress with CPP-115, including the grant of Fast Track development program designation by the U.S. Food and Drug Administration (FDA) for cocaine dependency and commencement of a first-in-man Phase I(a) safety study."